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Envarsus XR Tacrolimus .75 mg Tablet, Extended Release, 30-count — NDC 68992-3075-03 package photo

Envarsus XR Tacrolimus .75 mg Tablet, Extended Release, 30-count

by Veloxis Pharmaceuticals, Inc · 1 POUCH in 1 CARTON (68992-3075-3) / 1 BOTTLE, PLASTIC in 1 POUCH / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
NDC 68992-3075-03
🏷️ FDA NDC (as labeled) 68992-3075-3 billing pads the package segment with a zero
This package
Contains30-count Medicaid pays$5.16 / unit · 12 mo Per package$154.71 / 30 tablets · Medicaid Pack sizes2 compare ↓
Also priced by: Part D plans $6.86/unit — full pricing hub ↓
Also comes in: 100 tablets 68992-3075-01
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Tacrolimus (different manufacturers) — 3 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class I · Dec 23, 2024 — Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules (Astellas Pharma US Inc.) · FDA recall D-0211-2025
Class II · Feb 8, 2023 — Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules. (Dr. Reddy's Laboratories, Inc.) · FDA recall D-0330-2023
Class III · Jul 11, 2022 — Defective Container: Tube split from side seam (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-1304-2022
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 68992-3075-3
Product NDC 68992-3075
11-digit billing NDC 68992307503
NCPDP billing unit EA — each (per item)
RxCUI 1664434, 1664440, 1664456, 1664458, 1664461, 1664463
UNII WM0HAQ4WNM
UPC 0368992304033, 0368992301032, 0368992307539, 0368992301018 +1 more
Application # NDA206406
SPL Set ID de2315b0-6344-43ac-9aea-3e3b68d828e7
Established class (EPC) Calcineurin Inhibitor Immunosuppressant
Mechanism of action Calcineurin Inhibitors
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-09-01
Route ORAL
Dosage form TABLET, EXTENDED RELEASE
Substance TACROLIMUS
GPI-14 99404080007510
GPI class Envarsus XR
GCN Seq No 074467
GCN 39120
HICL code 020974
Ingredient (HICL) Tacrolimus
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z2
Therapeutic class — intermediate (HIC2) Antihistamines, Antiserotonins, Immunosuppressants
HIC3 code Z2E
Therapeutic class — specific (HIC3) Immunosuppressives
AHFS code 84:06.28.00
AHFS class Immunomodulatory Agents (84:06)
FDB label name ENVARSUS XR 0.75 MG TABLET
FDB brand name Envarsus Xr
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 68992-3075-3 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 68992-3075-03. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Calcineurin Inhibitor Immunosuppressant class.

Pharmacologic class Calcineurin Inhibitor Immunosuppressant
Drug family (ATC) Agents for dermatitis, excluding corticosteroids, Calcineurin inhibitors
How it works Calcineurin Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerVeloxis Pharmaceuticals, Inc
Application holderVELOXIS PHARMACEUTICALS INC
FDA applicationNDA206406 (NDA)
Labeler code68992
First marketedSep 2015
Product typeHuman Prescription Drug
Portfolio3 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name ENVARSUS XR 0.75 MG TABLET Ingredient Tacrolimus
📖 What it is MedlinePlus · NLM

Tacrolimus (Astagraf XL, Envarsus XR, Prograf) is used along with other medications to prevent rejection (attack of a transplanted organ by the immune system of a person receiving the organ) in people who have received a kidney transplant. Tacrolimus (Prograf) is also used along with other medications to prevent rejection in people who have received a liver, lung, or heart transplant. Tacrolimus is in a class of medications called immunosupressants. It works by decreasing the activity of the immune system to prevent it from attacking the transplanted organ.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • That's a great question, and it's one of the most important things to understand. Your body's immune system doesn't just stop trying to attack the new organ once you leave the hosp...
  • Why do I have to take tacrolimus even when I feel completely fine?
  • It actually does matter — but the key is being consistent, not choosing one over the other. Food can change how much tacrolimus your body absorbs, so if you always take it the same...
  • Does it matter if I take tacrolimus with food or on an empty stomach?
📖 Read our full Tacrolimus guide →
1
Nutrient depletion considerations

Tacrolimus may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Tacrolimus nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color White
ShapeOval
Imprint4;TCS
Size16 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 1P9D0Z171K
    BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII LQA7B6G8JG
    A synthetic polymer made by combining water-soluble compounds. It acts as a surfactant and solubilizer to help mix oil and water-based ingredients, improving the medicine's texture and how active ingredients dissolve.
  • UNII 30IQX730WE
    Polyethylene glycol 6000 is a synthetic polymer made from ethylene glycol units. It acts as a binder, filler, and solubilizer in medicines to help hold ingredients together, add bulk, and improve how well active drugs dissolve and absorb.
  • UNII W4888I119H
    Tartaric acid is a natural organic acid found in grapes and tamarinds. In medicines, it works as a buffer to control acidity, an antioxidant to prevent spoilage, and sometimes a flavoring or binding agent.

8 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $5.16 $154.71 / 30 tablets
Medicare drug plans payPart D · Q2 2026 $6.86 $205.94 / 30 tablets
Medicare Part B allowsASP · J7503 $1.863 / J7503 unit —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🧾 Billing & reimbursement

FDA NDC (as labeled)68992-3075-3
11-digit billing NDC68992-3075-03
Format5-4-1 as registered → padded to 5-4-2 for billing (zero added to the package segment)
HCPCS J-codeJ7503
DescriptorTACROLIMUS, EXTENDED RELEASE, (ENVARSUS XR), ORAL, 0.25 MG
Billing units / pkg3 units
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Envarsus XR .75 mgthis 68992-3075-03 Veloxis 30 tablets — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2015
First FDA approval
Jul 2015
📍
2026
Currently FDA-listed
11 years listed
🛡️
2028
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Aug 2028. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jul 10, 2015 RLD RS ⏳ ~2 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 8664239 — method of use (U-1752)
US 8685998 — method of use (U-1752)
US 8685998 — method of use (U-1752)
US 8664239 — method of use (U-1752)
US 8685998 — method of use (U-1752)
US 8664239 — method of use (U-1752)
US 8685998 — method of use (U-2678)
US 8685998 — method of use (U-2677)
US 8685998 — method of use (U-2678)
US 8685998 — method of use (U-2677)
US 8685998 — method of use (U-2677)
US 8685998 — method of use (U-2678)
US 11123331 — method of use (U-2677)
US 11123331 — method of use (U-2677)
US 11123331 — method of use (U-2677)
US 8664239 — method of use (U-2677)
US 8664239 — method of use (U-2677)
US 8664239 — method of use (U-2677)
US 11110081 — method of use (U-2678)
US 11110081 — method of use (U-2678)
US 11110081 — method of use (U-2678)
US 12083103 — method of use (U-2678)
US 12083103 — method of use (U-2678)
US 12083103 — method of use (U-2678)
US 8664239 — method of use (U-2678)
US 8664239 — method of use (U-2678)
US 8664239 — method of use (U-2678)
US 10864199 — method of use (U-2678)
US 10864199 — method of use (U-2677)
US 10864199 — method of use (U-2677)
US 10864199 — method of use (U-2678)
US 10864199 — method of use (U-2677)
US 10864199 — method of use (U-2678)
US 10166190 — drug product
US 11419823 — drug product
US 9549918 — drug product
US 11419823 — drug product
US 9549918 — drug product
US 9549918 — drug product
US 12403095 — drug product
US 11419823 — drug product
US 12403095 — drug product
US 10166190 — drug product
US 12403095 — drug product
US 10166190 — drug product
2015 2017 2019 2021 2023 2025 2027
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (45)
PatentTypeUse codeExpires
US 8664239 ↗ Method of use U-1752 Aug 30, 2028
US 8685998 ↗ Method of use U-1752 Aug 30, 2028
US 8685998 ↗ Method of use U-1752 Aug 30, 2028
US 8664239 ↗ Method of use U-1752 Aug 30, 2028
US 8685998 ↗ Method of use U-1752 Aug 30, 2028
US 8664239 ↗ Method of use U-1752 Aug 30, 2028
US 8685998 ↗ Method of use U-2678 Aug 30, 2028
US 8685998 ↗ Method of use U-2677 Aug 30, 2028
US 8685998 ↗ Method of use U-2678 Aug 30, 2028
US 8685998 ↗ Method of use U-2677 Aug 30, 2028
US 8685998 ↗ Method of use U-2677 Aug 30, 2028
US 8685998 ↗ Method of use U-2678 Aug 30, 2028
US 11123331 ↗ Method of use U-2677 May 30, 2028
US 11123331 ↗ Method of use U-2677 May 30, 2028
US 11123331 ↗ Method of use U-2677 May 30, 2028
US 8664239 ↗ Method of use U-2677 Aug 30, 2028
US 8664239 ↗ Method of use U-2677 Aug 30, 2028
US 8664239 ↗ Method of use U-2677 Aug 30, 2028
US 11110081 ↗ Method of use U-2678 May 30, 2028
US 11110081 ↗ Method of use U-2678 May 30, 2028
US 11110081 ↗ Method of use U-2678 May 30, 2028
US 12083103 ↗ Method of use U-2678 May 30, 2028
US 12083103 ↗ Method of use U-2678 May 30, 2028
US 12083103 ↗ Method of use U-2678 May 30, 2028
US 8664239 ↗ Method of use U-2678 Aug 30, 2028
US 8664239 ↗ Method of use U-2678 Aug 30, 2028
US 8664239 ↗ Method of use U-2678 Aug 30, 2028
US 10864199 ↗ Method of use U-2678 May 30, 2028
US 10864199 ↗ Method of use U-2677 May 30, 2028
US 10864199 ↗ Method of use U-2677 May 30, 2028
US 10864199 ↗ Method of use U-2678 May 30, 2028
US 10864199 ↗ Method of use U-2677 May 30, 2028
US 10864199 ↗ Method of use U-2678 May 30, 2028
US 10166190 ↗ Drug product — May 30, 2028
US 11419823 ↗ Drug product — May 30, 2028
US 9549918 ↗ Drug product — May 30, 2028
US 11419823 ↗ Drug product — May 30, 2028
US 9549918 ↗ Drug product — May 30, 2028
US 9549918 ↗ Drug product — May 30, 2028
US 12403095 ↗ Drug product — May 30, 2028
US 11419823 ↗ Drug product — May 30, 2028
US 12403095 ↗ Drug product — May 30, 2028
US 10166190 ↗ Drug product — May 30, 2028
US 12403095 ↗ Drug product — May 30, 2028
US 10166190 ↗ Drug product — May 30, 2028
Common questions
Is there a generic version of ENVARSUS XR 0.75 MG TABLET?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for ENVARSUS XR 0.75 MG TABLET. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Aug 2028 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 68992-3075-03, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
3.6K
Units reimbursed last 4 qtrs
216.9K
Gross reimbursed last 4 qtrs
$1.12M
Avg / prescription
$314.73
Avg / unit
$5.1571
Latest quarter Q4 2025
991Rx
Fee-for-service vs managed care ⓘ
72% FFS 28% MCO
Fee-for-service · 2,544 Rx Managed care · 1,010 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 3,030 units · 38.8 per 100k residents WA Idaho: 4,975 units · 253 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 1,530 units · 26.7 per 100k residents MN Wisconsin: 13,770 units · 233 per 100k residents WI Michigan: 4,422 units · 44.1 per 100k residents MI New York: 9,763 units · 49.9 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: 5,552 units · 174 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 19,438 units · 155 per 100k residents IL Indiana: 3,730 units · 54.4 per 100k residents IN Ohio: 8,070 units · 68.5 per 100k residents OH Pennsylvania: 4,601 units · 35.5 per 100k residents PA New Jersey: 3,300 units · 35.5 per 100k residents NJ Massachusetts: 6,963 units · 99.5 per 100k residents MA California: 76,374 units · 196 per 100k residents CA Utah: 11,460 units · 335 per 100k residents UT Colorado: 2,789 units · 47.4 per 100k residents CO Nebraska: no data reported NE Missouri: 1,830 units · 29.5 per 100k residents MO Kentucky: no data reported KY West Virginia: 1,740 units · 98.3 per 100k residents WV Virginia: 8,037 units · 92.2 per 100k residents VA Maryland: no data reported MD Connecticut: 1,450 units · 40.1 per 100k residents CT Rhode Island: no data reported RI Arizona: 650 units · 8.7 per 100k residents AZ New Mexico: 1,350 units · 63.9 per 100k residents NM Kansas: no data reported KS Arkansas: 2,041 units · 66.5 per 100k residents AR Tennessee: no data reported TN North Carolina: 8,790 units · 81.1 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: 1,280 units · 43.5 per 100k residents MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 5,280 units · 17.3 per 100k residents TX Florida: 4,682 units · 20.7 per 100k residents FL
Units reimbursed · per 100k residents
8.7335
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Utah 335 /100k
2 Idaho 253 /100k
3 Wisconsin 233 /100k
4 California 196 /100k
5 Nevada 174 /100k
6 Illinois 155 /100k
7 Massachusetts 99.5 /100k
8 West Virginia 98.3 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
100 tablets68992-3075-01 5,066 Rx · $1,514,560
30 tablets this page68992-3075-03 3,554 Rx · $1,118,547
Drug total (last 4 qtrs): 8,620 Rx · 554,767 units · $2,633,107 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Envarsus XR — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Envarsus XR. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$4.99M
Claims incl. refills
6K
Beneficiaries
2.5K
Spend / beneficiary
$1,999.98
Spend / claim
$833.58
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Tacrolimus — the ingredient across all brands.

Top reported reactions

Drug Interaction6,430
Acute Kidney Injury6,154
Diarrhoea5,965
Death5,065
Transplant Rejection5,034
Pyrexia4,886
Cytomegalovirus Infection4,655

Age at onset

Neonate649
Infant577
Child2,326
Adolescent1,343
Adult17,536
Elderly5,191

Reporter sex

156,020 reports
Male · 56%
Female · 44%
Unknown · 1%

Serious outcomes

Disabling2,296
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 14,638 6,631
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
68992-3075-01 1 POUCH in 1 CARTON (68992-3075-1) / 1 BOTTLE in 1 POUCH / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE 2015-09-01 Active
68992-3075-03 You're viewing this 1 POUCH in 1 CARTON (68992-3075-3) / 1 BOTTLE, PLASTIC in 1 POUCH / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC 2015-09-01 Active

This pack accounts for about 41% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in NDC 68992-3075-03?
NDC 68992-3075-03 is a 30-count package — 1 pouch in 1 carton / 1 bottle, plastic in 1 pouch / 30 tablet, extended release in 1 bottle, plastic.
What is the difference between NDC 68992-3075-03 and NDC 68992-3075-01?
Both are Envarsus XR Tacrolimus .75 mg Tablet, Extended Release — the drug itself is identical. NDC 68992-3075-03 is the 30-count package, while NDC 68992-3075-01 is the 100 tablets package.
What NDC number is used to bill for this package of Envarsus XR Tacrolimus .75 mg Tablet, Extended Release?
Bill NDC 68992-3075-03 — the 11-digit billing format is 68992307503. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 68992-3075-3, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 68992-3075-03, written without dashes as 68992307503. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 68992-3075-03, the first segment (68992) is the labeler code FDA assigned to Veloxis Pharmaceuticals, Inc; the middle segment (3075) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Veloxis Pharmaceuticals, Inc. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 100 tablets (68992-3075-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Veloxis Pharmaceuticals, Inc is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J7503 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning 73 words ▾

WARNING: MALIGNANCIES AND SERIOUS INFECTIONS Increased risk for developing serious infections and malignancies with ENVARSUS XR or other immunosuppressants that may lead to hospitalization or death [see Warnings and Precautions (5.1 , 5.2 )]. WARNING: MALIGNANCIES AND SERIOUS INFECTIONS See full prescribing information for complete boxed warning. Increased risk for developing serious infections and malignancies with ENVARSUS XR or other immunosuppressants that may lead to hospitalization or death.

( 5.1 , 5.2 )

🎯 Indications and Usage 131 words ▾

1 INDICATIONS AND USAGE ENVARSUS XR is a calcineurin-inhibitor immunosuppressant indicated for: The prophylaxis of organ rejection in de novo kidney transplant patients in combination with other immunosuppressants ( 1.1 ) The prophylaxis of organ rejection in kidney transplant patients converted from tacrolimus immediate-release formulations in combination with other immunosuppressants ( 1.2 )

1.1Prophylaxis of Organ Rejection in De Novo Kidney Transplant Patients ENVARSUS XR is indicated for the prophylaxis of organ rejection in kidney transplant patients in combination with other immunosuppressants [see Clinical Studies (14.1) ].

1.2Prophylaxis of Organ Rejection in Stable Kidney Transplant Patients Converting from Immediate-Release Formulations ENVARSUS XR is indicated for the prophylaxis of organ rejection in kidney transplant patients converted from tacrolimus immediate-release formulations, in combination with other immunosuppressants [see Clinical Studies (14.2) ].

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Take once daily on empty stomach at the same time of the day, preferably in the morning. ( 2.1 ) Avoid eating grapefruit or drinking grapefruit juice or alcohol. ( 2.1 ) African-American patients may need to be titrated to higher dosages to achieve the target tacrolimus concentrations.

( 2.4 ) Patients with severe hepatic impairment may require a lower starting dose. ( 2.4 ) Frequent monitoring of trough concentrations is recommended. ( 2.5 ) Recommended ENVARSUS XR Initial Dosage Initial Oral Dosage Whole Blood Trough Concentration Range De novo kidney transplantation with antibody induction 0.14 mg/kg/day Month 1: 6-11 ng/mL >Month 1: 4-11 ng/mL Conversion from tacrolimus immediate-release formulations 80% of the pre-conversion dose of tacrolimus immediate-release Titrate to 4-11 ng/mL

2.1Important Administration Instructions ENVARSUS XR (tacrolimus extended-release tablets) is not interchangeable or substitutable with tacrolimus extended-release capsules, tacrolimus capsules, and tacrolimus for oral suspension. Under or overexposure to tacrolimus may result in graft rejection or other serious adverse reactions [see Warnings and Precautions (5.3) ]. ENVARSUS XR should not be used without the supervision of a physician with experience in immunosuppressive therapy.

ENVARSUS XR should be taken on an empty stomach consistently at the same time of the day, preferably in the morning to ensure consistent and maximum possible drug exposure, at least 1 hour before a meal or at least 2 hours after a meal [see Clinical Pharmacology (12.3) ]. Advise patients to swallow ENVARSUS XR tablets whole with fluid (preferably water); patients must not chew, divide, crush or dissovle the tablets. If a dose is missed, instruct the patient to take it as soon as possible within 15 hours after missing the dose.

Beyond the 15-hour time frame, instruct the patient to wait until the usual scheduled time to take the next regular daily dose. Instruct the patient not to double the next dose. Patients should avoid eating grapefruit or drinking grapefruit juice or alcoholic beverage while taking ENVARSUS XR [see Drug Interactions (7.2) ].

2.2Dosing in De Novo Kidney Transplant Patients The recommended starting dose of ENVARSUS XR in de novo kidney transplant patients is 0.14 mg/kg/day. Titrate ENVARSUS XR dosage based on clinical assessments of rejection and tolerability and to achieve whole blood trough concentration ranges (see Table 1 ). Table 1.

Recommended Tacrolimus Whole Blood Trough Concentration Ranges in Kidney Transplant Patients with Antibody Induction Time Period Post Transplant Target Tacrolimus Whole Blood Trough Concentration Ranges During Month 1 6 to 11 ng/mL > Month 1 4 to 11 ng/mL

2.3Dosing for Conversion from Tacrolimus Immediate-Release Formulations To convert from a tacrolimus immediate-release product to ENVARSUS XR, administer ENVARSUS XR once daily at a dose that is 80% of the total daily dose of the tacrolimus immediate-release product. Monitor tacrolimus whole blood trough concentrations and titrate ENVARSUS XR dosage to achieve whole blood trough concentration ranges of 4 to 11 ng/mL.

2.4Dosing Adjustments in African-American Patients, Patients with Hepatic Impairment, Drug Interactions African-American patients, compared to Caucasian patients, may need to be titrated to higher ENVARSUS XR dosages to attain comparable trough concentrations [see Use in Specific Populations (8.8) , Clinical Pharmacology (12.3) ]. Due to reduced clearance and prolonged half-life seen in patients with severe hepatic impairment (Child-Pugh ≥10) these patients may require a lower starting dosage of ENVARSUS XR [see Clinical Pharmacology (12.3) ].

Dose adjustments of ENVARSUS XR may be necessary when administered concomitantly with CYP3A inducers or CYP3A inhibitors or cannabidiol [see Warnings and Precautions (5.9 , 5.13) , Drug Interactions (7.2 , 7.3) ].

2.5 Therapeutic Drug Monitoring Measure tacrolimus whole blood tr…

💊 Dosage Forms and Strengths 62 words ▾

3 DOSAGE FORMS AND STRENGTHS Oval, white to off-white uncoated extended-release tablets debossed with “TCS” on one side: 0.75 mg extended-release tablet: debossed with “0.75” on the other side. 1 mg extended-release tablet: debossed with “1” on the other side. 4 mg extended-release tablet: debossed with “4” on the other side. Extended-release tablets: 0.75 mg, 1 mg, 4 mg ( 3 )

⛔ Contraindications 34 words ▾

4 CONTRAINDICATIONS ENVARSUS XR is contraindicated in patients with known hypersensitivity to tacrolimus or to any of the ingredients in ENVARSUS XR. Known hypersensitivity to tacrolimus or any of the ingredients ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Not Interchangeable with Other Tacrolimus Products: Instruct patients or caregivers to recognize appearance of ENVARSUS XR tablets. ( 5.3 ) New Onset Diabetes after Transplant: Monitor blood glucose. ( 5.4 ) Nephrotoxicity (acute and/or chronic): May occur due to ENVARSUS XR, drug interactions or concomitant nephrotoxic drugs.

Monitor renal function and tacrolimus blood concentrations; consider dosage reduction or temporary interruption of ENVARSUS. ( 5.5 ) Neurotoxicity: Including risk of posterior reversible encephalopathy syndrome (PRES); monitor for neurologic abnormalities; reduce dosage or discontinue ENVARSUS XR. ( 5.6 ) Hyperkalemia: Risk may be increased with other agents associated with hyperkalemia; monitor serum potassium levels.

( 5.7 ) Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. ( 5.8 ) QT Prolongation: Consider obtaining electrocardiograms and monitoring electrolytes in patients at high risk. ( 5.10 ) Immunizations: Avoid live vaccines.

( 5.11 ) Pure Red Cell Aplasia: Consider discontinuation. ( 5.12 ) Thrombotic Microangiopathy, Including Hemolytic Uremic Syndrome and Thrombotic Thrombocytopenic Purpura: May occur, especially in patients with infections and certain concomitant medications. ( 5.14 )

5.1Lymphoma and Other Malignancies Immunosuppressants, including ENVARSUS XR, increase the risk of developing lymphomas and other malignancies, particularly of the skin. The risk appears to be related to the intensity and duration of immunosuppression rather than to the use of any specific agent. Examine patients for skin changes and advise to avoid or limit exposure to sunlight and UV light by wearing protective clothing and using a sunscreen with a high protection factor.

Post-transplant lymphoproliferative disorder (PTLD), associated with Epstein-Barr Virus (EBV), has been reported in immunosuppressed organ transplant patients. The risk of PTLD appears greatest in those individuals who are EBV seronegative. Monitor EBV serology during treatment.

5.2Serious Infections Immunosuppressants, including ENVARSUS XR, increase the risk of developing bacterial, viral, fungal, and protozoal infections, including opportunistic infections. These infections may lead to serious, including fatal, outcomes. Serious viral infections reported include: Polyomavirus-associated nephropathy (especially due to BK virus infection), JC virus-associated progressive multifocal leukoencephalopathy (PML), and Cytomegalovirus (CMV) infections: CMV seronegative transplant patients who receive an organ from a CMV seropositive donor are at highest risk of CMV viremia and CMV disease.

Monitor for the development of infection and adjust the immunosuppressive regimen to balance the risk of rejection with the risk of infection [see Adverse Reactions (6.1) ] .

5.3Not Interchangeable with Other Tacrolimus Products-Medication Errors Medication errors, including substitution and dispensing errors, between tacrolimus capsules and tacrolimus extended-release capsules were reported outside the U.S. This led to serious adverse reactions, including graft rejection, or other adverse reactions due to under- or over-exposure to tacrolimus. ENVARSUS XR is not interchangeable or substitutable with tacrolimus extended-release capsules, tacrolimus capsules or tacrolimus for oral suspension.

Instruct patients and caregivers to recognize the appearance of ENVARSUS XR tablet [see Dosage Forms and Strengths (3) ] and to confirm with their healthcare provider if a different product is dispensed or if dosing instructions have changed.

5.4New Onset Diabetes after Transplant ENVARSUS XR caused new onset diabetes after transplant (NODAT) in kidney transplant patients, which may be reversible in some patients. African-American and Hispanic kidney transplant patients are at an increased risk. Monitor blood glucose concentrations and treat appropriately [see Adverse Reactions (6.1) and Use in Specific Pop…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse drug reactions are discussed in greater detail in other sections of the labeling: Lymphoma and Other Malignancies [see Boxed Warning, Warnings and Precautions (5.1) ] Serious Infections [see Boxed Warning, Warnings and Precautions (5.2) ] New Onset Diabetes after Transplant [see Warnings and Precautions (5.4) ] Nephrotoxicity due to ENVARSUS XR and Drug Interactions [see Warnings and Precautions (5.5) ] Neurotoxicity [see Warnings and Precautions (5.6) ] Hyperkalemia [see Warnings and Precautions (5.7) ] Hypertension [see Warnings and Precautions (5.8) ] QT Prolongation [see Warnings and Precautions (5.10) ] Pure Red Cell Aplasia [see Warnings and Precautions (5.12) ] Thrombotic Microangiopathy, Including Hemolytic Uremic Syndrome and Thrombotic Thrombocytopenic Purpura [see Warnings and Precautions (5.13) ] De novo kidney transplant patients: Most common adverse reactions (incidence ≥15%) include: diarrhea, anemia, urinary tract infection, hypertension, tremor, constipation, diabetes mellitus, peripheral edema, hyperkalemia and headache.

( 6.1 ) Conversion of kidney transplant patients from immediate-release to extended-release tacrolimus: Most common adverse reactions (incidence ≥10%) include: diarrhea and blood creatinine increased. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Veloxis Pharmaceuticals, Inc. at 1-844-VELOXIS (1-844-835-6947) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. In addition, the clinical studies were not designed to establish comparative differences across study arms with regards to the adverse reactions discussed below. Study 1- Phase 3 Clinical Study in De Novo Kidney Transplant Recipients Study 1 (NCT 01187953), was a Phase 3 randomized study in de novo kidney transplant patients that were treated with ENVARSUS XR (N=268) or tacrolimus [immediate-release] capsules (N=275) and concomitant immunosuppressants in a double-blind, randomized, multinational study [see Clinical Studies (14.1) ].

The proportion of patients who discontinued treatment due to adverse reactions was 8.6% and 9.8% in the ENVARSUS XR and tacrolimus capsules treatment groups, respectively, through 12 months of treatment. The most common adverse reactions leading to discontinuation of study drug in the ENVARSUS XR treatment group were esophagitis, polyomavirus-associated nephropathy, graft dysfunction, complications of transplanted kidney, and diabetes mellitus, each resulting in 0.7% discontinuations among ENVARSUS XR treatment patients.

In Study 1, de novo kidney transplant patients who received a starting dose of 0.17 mg/kg/day, which is higher than the recommended ENVARSUS XR starting dose of 0.14 mg/kg/day, exceeded the recommended target tacrolimus trough concentrations as high as 57 ng/mL during the first 1 to 2 weeks post-transplant [see Dosage and Administration (2.2) ]. Infections The overall incidence of infections, serious infections, and infections with identified etiology reported in de novo kidney transplant recipients treated with ENVARSUS XR or tacrolimus [immediate-release] capsules in Study 1 are shown in Table 2 .

Table 2 Percentage of Patients with Infections Through 1 Year Post-Kidney Transplant in Study 1 a MMF/MPS- Mycophenolate mofetil/mycophenolate sodium; AZA-azathioprine a Study 1 was not designed to support comparative claims of ENVARSUS XR compared to tacrolimus [immediate-release] capsules for the adverse reactions reported in this table. b BK virus-associated nephropathy (BKVAN) occurred in 1.5% (4/268) and 0.7% (2/275) in the ENVARSUS XR and tacrolimus capsules treatment groups, respectively. ENVARSUS XR ± steroids, IL-2 recepto…

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS Risk of rejection with strong CYP3A inducers and risk of serious adverse reactions with strong CYP3A inhibitors: Adjust dose and monitor tacrolimus concentrations. ( 2.4 , 5.9 , 7.2 ) Therapeutic drug monitoring and dose reduction for ENVARSUS XR should be considered when ENVARSUS XR is co-administered with cannabidiol ( 2.5 , 5.13 , 7.3 ). See Full Prescribing Information for clinically significant drug interactions. ( 7.1 , 7.2 )

7.1Mycophenolic Acid When ENVARSUS XR is prescribed with a given dose of mycophenolic acid (MPA) product, exposure to MPA is higher with ENVARSUS XR co-administration than with cyclosporine co-administration with MPA, because cyclosporine interrupts the enterohepatic recirculation of MPA while tacrolimus does not. Monitor for MPA associated adverse reactions and reduce the dose of concomitantly administered MPA products as needed.

7.2Effects of Other Drugs/Substances on ENVARSUS XR Table 7. Effects of Other Drugs/Substances on ENVARSUS XR a, d a ENVARSUS XR dosage adjustment recommendation based on observed effect of co-administered drug on tacrolimus exposures [see Clinical Pharmacology (12.3) ] , literature reports of altered tacrolimus exposures, or the other drug’s known CYP3A inhibitor/inducer status b High dose or double strength grapefruit juice is a strong CYP3A inhibitor; low dose or single strength grapefruit juice is a moderate CYP3A inhibitor c Strong CYP3A inhibitor/inducer, based on reported effect on exposures to immediate-release tacrolimus along with supporting in vitro CYP3A inhibitor/inducer data, or based on drug-drug interaction studies with midazolam (sensitive CYP3A probe substrate) d A drug interaction study with voriconazole was conducted for ENVARSUS XR [see Clinical Pharmacology (12.3) ] .

No other drug-drug interaction studies were conducted with ENVARSUS XR. Drug/Substance Class or Name Drug Interaction Effect Recommendations Grapefruit or grapefruit juice b May increase tacrolimus whole blood trough concentrations and increase the risk of serious adverse reactions (e.g., neurotoxicity, QT prolongation) [see Warnings and Precautions (5.6 , 5.9 , 5.10) ]. Avoid grapefruit or grapefruit juice.

Alcohol May modify the rate of tacrolimus release. Avoid alcoholic beverages. Strong CYP3A Inducers c, such as: Antimycobacterials (e.g., rifampin, rifabutin), anticonvulsants (e.g., phenytoin, carbamazepine and phenobarbital), St John’s Wort May decrease tacrolimus whole blood trough concentrations and increase the risk of rejection [see Warnings and Precautions (5.9) ].

Increase ENVARSUS XR dose and monitor tacrolimus whole blood trough concentrations [see Dosage and Administration (2.5) and Clinical Pharmacology (12.3) ]. Strong CYP3A Inhibitors c, , such as: Protease inhibitors (e.g., nelfinavir, telaprevir, boceprevir, ritonavir or ritonavir containing products), azole antifungals (e.g., voriconazole, posaconazole, itraconazole, ketoconazole), antibiotics (e.g., clarithromycin, troleandomycin, chloramphenicol), nefazodone, Schisandra sphenanthera extracts, cobicistat May increase tacrolimus whole blood trough concentrations and increase the risk of serious adverse reactions (e.g., neurotoxicity, QT prolongation).

A rapid, sharp rise in tacrolimus levels may occur early, despite an immediate reduction of tacrolimus dose [see Warnings and Precautions (5.6, 5.9, 5.10) ]. Reduce ENVARSUS XR dose (for voriconazole and posaconazole, give one-third of the original dose) and adjust dose based on tacrolimus whole blood trough concentrations [see Dosage and Administration (2.5) and Clinical Pharmacology (12.3) ]. Early and frequent monitoring of tacrolimus whole blood trough levels should start within 1-3 days and continue monitoring as necessary [see Warnings and Precautions (5.9)] .

Mild or Moderate CYP3A Inhibitors, such as: antibiotics (e.g., erythromycin), calcium channel blockers (e.g., verapamil, diltiazem, nifedipine, nicardipine), amiodarone, danazol, ethiny…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS ­Pregnancy: Can cause fetal harm. Advise pregnant women of the potential risk to the fetus. ( 8.1 , 8.3 )

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy registry that monitors pregnancy outcomes in women exposed to ENVARSUS XR during pregnancy. The Transplantation Pregnancy Registry International (TPRI) is a voluntary pregnancy exposure registry that monitors outcomes of pregnancy in female transplant recipients and those fathered by male transplant recipients exposed to immunosuppressants including tacrolimus. Healthcare providers are encouraged to advise their patients to register by contacting the Transplantation Pregnancy Registry International at 1-877-955-6877 or https://www.transplantpregnancyregistry.org.

Risk Summary Tacrolimus can cause fetal harm when administered to a pregnant woman. Data from postmarketing surveillance and TPRI suggest that infants exposed to tacrolimus in utero are at a risk of prematurity, birth defects/congenital anomalies, low birth weight, and fetal distress [see Human Data]. Advise pregnant women of the potential risk to the fetus.

Administration of oral tacrolimus to pregnant rabbits and rats throughout the period of organogenesis was associated with maternal toxicity/lethality, and an increased incidence of abortion, malformation and embryofetal death at clinically relevant doses (0.7 to 3.7 times the recommended clinical dose [0.14 mg/kg/day], on a mg/m² basis). Administration of oral tacrolimus to pregnant rats after organogenesis and throughout lactation produced maternal toxicity, effects on parturition, reduced pup viability and reduced pup weight at clinically relevant doses (1.2 to 3.7 times the recommended clinical dose, on a mg/m² basis).

Administration of oral tacrolimus to rats prior to mating, and throughout gestation and lactation produced maternal toxicity/lethality, marked effects on parturition, embryofetal loss, malformations, and reduced pup viability at clinically relevant doses (1.2 to 3.7 times the recommended clinical dose, on a mg/m² basis). Interventricular septal defects, hydronephrosis, craniofacial malformations and skeletal effects were observed in offspring that died [see Animal Data]. The background risk of major birth defects and miscarriage in the indicated population is unknown.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 % and 15 to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo-Fetal Risk Risks during pregnancy are increased in organ transplant recipients. The risk of premature delivery following transplantation is increased.

Pre-existing hypertension and diabetes confer additional risk to the pregnancy of an organ transplant recipient. Pre-gestational and gestational diabetes are associated with birth defects/congenital anomalies, hypertension, low birth weight and fetal death. Cholestasis of pregnancy (COP) was reported in 7% of liver or liver-kidney (LK) transplant recipients, compared with approximately 1% of pregnancies in the general population.

However, COP symptoms resolved postpartum and no long-term effects on the offspring were reported. Maternal Adverse Reactions ENVARSUS XR may increase hyperglycemia in pregnant women with diabetes (including gestational diabetes). Monitor maternal blood glucose levels regularly [see Warnings and Precautions (5.4) ].

ENVARSUS XR may exacerbate hypertension in pregnant women and increase pre-eclampsia. Monitor and control blood pressure [see Warnings and Precautions (5.7 , 5.8) ]. Fetal/Neonatal Adverse Reactions Renal dysfunction, transient neonatal hyperkalemia and low birth weight have been reported at the time of delivery in infants of mothers taking ENVARSUS XR.

Labor or Delivery There is an increased risk for premature delivery (<37 weeks) following transplantation and maternal exposure to ENVARSUS XR. Data Human Data T…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy registry that monitors pregnancy outcomes in women exposed to ENVARSUS XR during pregnancy. The Transplantation Pregnancy Registry International (TPRI) is a voluntary pregnancy exposure registry that monitors outcomes of pregnancy in female transplant recipients and those fathered by male transplant recipients exposed to immunosuppressants including tacrolimus. Healthcare providers are encouraged to advise their patients to register by contacting the Transplantation Pregnancy Registry International at 1-877-955-6877 or https://www.transplantpregnancyregistry.org.

Risk Summary Tacrolimus can cause fetal harm when administered to a pregnant woman. Data from postmarketing surveillance and TPRI suggest that infants exposed to tacrolimus in utero are at a risk of prematurity, birth defects/congenital anomalies, low birth weight, and fetal distress [see Human Data]. Advise pregnant women of the potential risk to the fetus.

Administration of oral tacrolimus to pregnant rabbits and rats throughout the period of organogenesis was associated with maternal toxicity/lethality, and an increased incidence of abortion, malformation and embryofetal death at clinically relevant doses (0.7 to 3.7 times the recommended clinical dose [0.14 mg/kg/day], on a mg/m² basis). Administration of oral tacrolimus to pregnant rats after organogenesis and throughout lactation produced maternal toxicity, effects on parturition, reduced pup viability and reduced pup weight at clinically relevant doses (1.2 to 3.7 times the recommended clinical dose, on a mg/m² basis).

Administration of oral tacrolimus to rats prior to mating, and throughout gestation and lactation produced maternal toxicity/lethality, marked effects on parturition, embryofetal loss, malformations, and reduced pup viability at clinically relevant doses (1.2 to 3.7 times the recommended clinical dose, on a mg/m² basis). Interventricular septal defects, hydronephrosis, craniofacial malformations and skeletal effects were observed in offspring that died [see Animal Data]. The background risk of major birth defects and miscarriage in the indicated population is unknown.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 % and 15 to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo-Fetal Risk Risks during pregnancy are increased in organ transplant recipients. The risk of premature delivery following transplantation is increased.

Pre-existing hypertension and diabetes confer additional risk to the pregnancy of an organ transplant recipient. Pre-gestational and gestational diabetes are associated with birth defects/congenital anomalies, hypertension, low birth weight and fetal death. Cholestasis of pregnancy (COP) was reported in 7% of liver or liver-kidney (LK) transplant recipients, compared with approximately 1% of pregnancies in the general population.

However, COP symptoms resolved postpartum and no long-term effects on the offspring were reported. Maternal Adverse Reactions ENVARSUS XR may increase hyperglycemia in pregnant women with diabetes (including gestational diabetes). Monitor maternal blood glucose levels regularly [see Warnings and Precautions (5.4) ].

ENVARSUS XR may exacerbate hypertension in pregnant women and increase pre-eclampsia. Monitor and control blood pressure [see Warnings and Precautions (5.7 , 5.8) ]. Fetal/Neonatal Adverse Reactions Renal dysfunction, transient neonatal hyperkalemia and low birth weight have been reported at the time of delivery in infants of mothers taking ENVARSUS XR.

Labor or Delivery There is an increased risk for premature delivery (<37 weeks) following transplantation and maternal exposure to ENVARSUS XR. Data Human Data There are no adequate and well controlled studies on the effects of tacrolimus in human pregnancy. Safety data from the TPRI and postmark…

🧒 Pediatric Use 17 words ▾

8.4Pediatric Use The safety and effectiveness of ENVARSUS XR in pediatric patients have not been established.

🧓 Geriatric Use 113 words ▾

8.5Geriatric Use Clinical studies of ENVARSUS XR did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. In Studies 1, 2 and 3, there were 37 patients 65 years of age and older, and no patients were over 75 years [see Clinical Studies (14) ] . Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

🆘 Overdosage 140 words ▾

10 OVERDOSAGE Postmarketing cases of overdose with tacrolimus have been reported. Overdosage adverse reactions included: nervous system disorders (tremor, headache, confusional state, balance disorders, encephalopathy, lethargy and somnolence) gastrointestinal disturbances (nausea, vomiting, and diarrhea) abnormal renal function (increased blood urea nitrogen and elevated serum creatinine) urticaria hypertension peripheral edema, and infections (one fatal postmarketing case of bilateral pneumopathy and CMV infection was attributed to tacrolimus extended-release capsules overdose).

Based on the poor aqueous solubility and extensive erythrocyte and plasma protein binding, it is anticipated that tacrolimus is not dialyzable to any significant extent; there is no experience with charcoal hemoperfusion. The oral use of activated charcoal has been reported in treating acute overdoses, but experience has not been sufficient to warrant recommending its use. General supportive measures and treatment of specific symptoms should be followed in all cases of overdosage.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Tacrolimus binds to an intracellular protein, FKBP-12. A complex of tacrolimus-FKBP-12, calcium, calmodulin, and calcineurin (an ubiquitous mammalian intracellular enzyme) is then formed and the phosphatase activity of calcineurin inhibited. Such inhibition prevents the dephosphorylation and translocation of various factors such as the nuclear factor of activated T-cells (NF-AT) and nuclear factor kappa-light-chain-enhancer of activated B-cells (NF-κB).

Tacrolimus inhibits the expression and/or production of several cytokines that include interleukin (IL)-1 beta, IL-2, IL-3, IL-4, IL-5, IL-6, IL-8, IL-10, gamma interferon, tumor necrosis factor-alpha, and granulocyte macrophage colony stimulating factor. Tacrolimus also inhibits IL-2 receptor expression and nitric oxide release, induces apoptosis and production of transforming growth factor-beta that can lead to immunosuppressive activity. The net result is the inhibition of T-lymphocyte activation and proliferation as well as T-helper-cell-dependent B-cell response (i.e., immunosuppression).

12.3Pharmacokinetics Table 9 summarizes the pharmacokinetic (PK) parameters of tacrolimus following oral administration of once-daily ENVARSUS XR in healthy subjects and in kidney transplant patients, under fasted conditions. Whole blood tacrolimus concentrations in the pharmacokinetic studies were measured using validated HPLC/MS/MS assays. Table 9.

Pharmacokinetic Parameters of ENVARSUS XR by Study Day in Healthy Subjects and Kidney Transplant Patients Under Fasted Conditions a) Healthy adult subjects (administered mg/day dose); Adult de novo kidney transplant patients (group average of administered mg/day dose); Adult kidney ≥ 6 months post-transplant (group average of administered mg/day dose of ENVARSUS XR, following conversion to 67% to 80% of the daily tacrolimus immediate -release capsules dose) b) Day of ENVARSUS XR dosing and PK profiling c) Arithmetic means ± S.D. d) Median [range] e) “ De novo ” refers to immunosuppression starting at the time of transplantation f) Starting ENVARSUS XR dose = 0.14 mg/kg/day g) Starting ENVARSUS XR dose = 0.17 mg/kg/day.

De novo kidney transplant patients who received ENVARSUS XR starting dose of 0.17 mg/kg/day achieved higher than recommended target tacrolimus trough concentrations, as high as 57 ng/mL during the first 1 to 2 weeks post-transplant. h) Tacrolimus trough concentration before the next dose i) After 7 days of stable dosing with ENVARSUS XR j) AUC 0-24 –to- C 24 correlation coefficient (r) at steady state was 0.80 or higher k) Conversion to ENVARSUS XR at a mean dose of 80% of the total daily dose of tacrolimus immediate-release resulted in equivalent exposure with a 30% reduction in C max .

Population ENVARSUS XR Dose Day b Pharmacokinetic Parameters of ENVARSUS XR C max c (ng/mL) T max d (hr) AUC 24 c (ng•hr/mL) C 24 h (ng/mL) Healthy Subjects a (n=19) 2 mg 2 mg Day 1 Day 10 11.9 ± 3.8 8.3 ± 2.9 14.0 [6 - 28] 8.0 [1.0-12.0] 50 ± 14 140 ± 50 1.8 ± 0.6 4.6 ±

1.7Adult Kidney a De novo e (n=21) 11.8 mg f 10 mg 9.5 mg Day 1 Day 7 Day 14 11.8 ± 7.2 25.1 ± 16.3 27.1 ± 13.4 8.0 [4-24] 6.0 [2-12] 4.0 [1-8] 138 ± 80 335 ± 129 371 ± 104 5.2 ± 2.7 9.9 ± 4.4 11.4 ± 4.1 j Adult Kidney a De novo (n=10) 15.5 mg g 11.4 mg 11.1 mg Day 1 Day 14 Day 28 33.6 ± 21.8 31.1 ± 14.6 35.9± 18.7 6.0 [4-24] 4.0 [1-18] 4.0 [1-14] 377 ± 257 376 ± 140 396 ± 150 11.0 ± 6.1 9.1 ± 3.0 10.5 ±

3.2Adult Kidney a (≥ 6 months post- transplant) (n=47) 5.3 mg Day 7 i 13.5 ± 4.8 6.0 [1 - 16] 216 ± 63 7.0 ± 2.3 j Adult African- American Kidney k (≥ 6 months post-transplant) (n=46) 7.8 mg Day 7 i 18.4 ± 7.2 5.0 [1 - 16] 272 ± 97 7.8 ± 2.9 j In de novo adult kidney transplant patients, the administration of ENVARSUS XR once daily at a starting dose of 0.14 mg/kg/day results in a tacrolimus systemic exposure (AUC 24 ) on Day 1 post-transplant that is up to 10% lower than that of tacrolimus immediate-release capsules twice da…

🧬 Mechanism of Action 136 words ▾

12.1Mechanism of Action Tacrolimus binds to an intracellular protein, FKBP-12. A complex of tacrolimus-FKBP-12, calcium, calmodulin, and calcineurin (an ubiquitous mammalian intracellular enzyme) is then formed and the phosphatase activity of calcineurin inhibited. Such inhibition prevents the dephosphorylation and translocation of various factors such as the nuclear factor of activated T-cells (NF-AT) and nuclear factor kappa-light-chain-enhancer of activated B-cells (NF-κB).

Tacrolimus inhibits the expression and/or production of several cytokines that include interleukin (IL)-1 beta, IL-2, IL-3, IL-4, IL-5, IL-6, IL-8, IL-10, gamma interferon, tumor necrosis factor-alpha, and granulocyte macrophage colony stimulating factor. Tacrolimus also inhibits IL-2 receptor expression and nitric oxide release, induces apoptosis and production of transforming growth factor-beta that can lead to immunosuppressive activity. The net result is the inhibition of T-lymphocyte activation and proliferation as well as T-helper-cell-dependent B-cell response (i.e., immunosuppression).

📦 How Supplied / Storage and Handling 144 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING ENVARSUS XR is supplied in round HDPE bottles with twist-off caps (see Table 12 ); the statement ‘ONCE-DAILY’ appears on its labels. Table 12. Strengths of ENVARSUS XR Strength Description NDC 0.75 mg Oval, white to off-white uncoated extended-release tablet, debossed with “0.75” on one side and “TCS” on the other side.

30-count (NDC 68992-3075-3) 100-count (NDC 68992-3075-1) 1 mg Oval, white to off-white uncoated extended-release tablet, debossed with “1” on one side and “TCS” on the other side. 30-count (NDC 68992-3010-3) 100-count (NDC 68992-3010-1) 4 mg Oval, white to off-white uncoated extended-release tablet, debossed with “4” on one side and “TCS” on the other side. 30-count (NDC 68992-3040-3) 100-count (NDC 68992-3040-1) Store and Dispense Store at 25 °C (77 °F); excursions permitted to 15 °C to 30 °C (59 °F to 86 °F) [see USP Controlled Room Temperature].

📋 Description 165 words ▾

11 DESCRIPTION Tacrolimus is the active ingredient in ENVARSUS XR. Tacrolimus is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as [3 S -[3 R *[ E (1 S *,3 S *,4 S *)],4 S *,5 R *,8 S *,9 E ,12 R *,14 R *,15 S *,16 R *,18 S *,19 S *,26a R *]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclo-hexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1- c ][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate.

The chemical structure of tacrolimus is: Tacrolimus has an empirical formula of C 44 H 69 NO 12 •H 2 O and a formula weight of 822.03. Tacrolimus appears as white crystals or crystalline powder. It is practically insoluble in water, freely soluble in ethanol, and very soluble in methanol and chloroform.

ENVARSUS XR is available for oral administration as extended-release tablets containing the equivalent of 0.75 mg, 1 mg, or 4 mg of anhydrous tacrolimus USP. Inactive ingredients include hypromellose USP, lactose monohydrate NF, polyethylene glycol NF, poloxamer NF, magnesium stearate NF, tartaric acid NF, butylated hydroxytoluene NF, and dimethicone NF. chemical-structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide).

17.1Administration Advise patients to: Inspect their ENVARSUS XR medicine when they receive a new prescription and before taking it. If the appearance of the tablet is not the same as usual, or if dosage instructions have changed, advise patients to contact their healthcare provider as soon as possible to make sure that you have the right medicine. Other tacrolimus products cannot be substituted for ENVARSUS XR [see Warnings and Precautions (5.3) ] .

Take once-daily ENVARSUS XR at the same time every day (preferably in the morning) on an empty stomach. at least 1 hour before or at least 2 hours after a meal to ensure consistent and maximum possible drug concentrations in the blood. Swallow tablet whole with liquid, preferably water. Do not chew, divide or crush tablet.

Avoid alcoholic beverages, grapefruit, and grapefruit juice while on ENVARSUS XR [see Dosage and Administration (2.1) and Drug Interactions (7.2) ] . Take a missed dose as soon as possible but not more than 15 hours after the scheduled time (i.e., for a missed 8 AM dose, take it no later than 10 PM). Beyond the 15-hour timeframe, instruct the patient to wait until the usual scheduled time the following morning to take the next regularly scheduled dose.

Do not take two doses at the same time [see Dosage and Administration (2.1) ] .

17.2Development of Lymphoma and Other Malignancies Inform patients that they are at an increased risk of developing lymphomas and other malignancies, particularly of the skin, due to immunosuppression. Advise patients to limit exposure to sunlight and ultraviolet (UV) light by wearing protective clothing and use a sunscreen with a high protection factor [see Boxed Warning and Warnings and Precautions (5.1) ] .

17.3Increased Risk of Infection Inform patients that they are at an increased risk of developing a variety of infections, including opportunistic infections, due to immunosuppression and to contact their physician if they develop any symptoms of infection such as fever, sweats or chills, cough or flu-like symptoms, muscle aches, or warm, red, painful areas on the skin [see Boxed Warning and Warnings and Precautions (5.2) ] .

17.4New Onset Diabetes After Transplant Inform patients that ENVARSUS XR can cause diabetes mellitus and should be advised to contact their physician if they develop frequent urination, increased thirst or hunger [see Warnings and Precautions (5.4) ] .

17.5Nephrotoxicity Inform patients that ENVARSUS XR can have toxic effects on the kidney that should be monitored. Advise patients to attend all visits and complete all blood tests ordered by their medical team [see Warnings and Precautions (5.5) ] .

17.6Neurotoxicity Inform patients that they are at risk of developing adverse neurologic effects including seizure, altered mental status, and tremor. Advise patients to contact their physician should they develop vision changes, delirium, or tremors [see Warnings and Precautions (5.6) ] .

17.7Hyperkalemia Inform patients that ENVARSUS XR can cause hyperkalemia. Monitoring of potassium levels may be necessary, especially with concomitant use of other drugs known to cause hyperkalemia [see Warnings and Precautions (5.7) ] .

17.8Hypertension Inform patients that ENVARSUS XR can cause high blood pressure which may require treatment with anti-hypertensive therapy. Advise patients to monitor their blood pressure [see Warnings and Precautions (5.8) ] .

17.9Thrombotic Microangiopathy Inform patients that ENVARSUS XR can cause blood clotting problems. The risk of this occurring increases when patients take ENVARSUS XR and sirolimus or everolimus concomitantly, or when patients develop certain infections. Advise them to seek medical attention promptly if they develop fever, petequiae or bruises, fatigue, confusion, jaundice, oliguria [see Warnings and Precautions (5.13) ].

17.10 Drug Interactions Instr…

💬 Medication Guide ~3 min read ▾

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 4/2024 MEDICATION GUIDE ENVARSUS XR® (En var' sus XR) (tacrolimus extended-release tablets) for oral use Read this Medication Guide before you start taking ENVARSUS XR and each time you get a refill.

There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. If you have any questions about ENVARSUS XR, ask your healthcare provider or pharmacist.

What is the most important information I should know about ENVARSUS XR? ENVARSUS XR can cause serious side effects, including: Increased risk of cancer. People who take ENVARSUS XR have an increased risk of getting some kinds of cancer, including skin and lymph gland cancer (lymphoma).

Increased risk of infection. ENVARSUS XR is a medicine that affects your immune system. ENVARSUS XR can lower the ability of your immune system to fight infections.

Serious infections can happen in people receiving ENVARSUS XR that can cause death. Call your healthcare provider right away if you have symptoms of an infection such as: fever sweats or chills cough or flu-like symptoms muscle aches warm, red, or painful areas on your skin What is ENVARSUS XR? ENVARSUS XR is a prescription medicine used with other medicines to help prevent organ rejection in people who have had a kidney transplant.

ENVARSUS XR is an extended-release tablet and is not the same as tacrolimus extended-release capsules, tacrolimus immediate-release capsules or tacrolimus for oral suspension. Your healthcare provider should decide what medicine is right for you. It is not known if Envarsus XR is safe and effective in children.

Who should not take ENVARSUS XR? Do not take ENVARSUS XR if you: are allergic to tacrolimus or any of the ingredients in ENVARSUS XR. See the end of this Medication Guide for a complete list of ingredients in ENVARSUS XR.

What should I tell my doctor before taking ENVARSUS XR? Before you take ENVARSUS XR, tell your healthcare provider about all your medication conditions, including if you: plan to receive any live vaccines. Ask your healthcare provider if you are not sure if your vaccine is a live vaccine. have or have had liver, kidney or heart problems. are pregnant or plan to become pregnant.

ENVARSUS XR may harm your unborn baby. If you are able to become pregnant, you should use effective birth control before and during treatment with ENVARSUS XR. Talk to your healthcare provider about birth control methods that may be right for you.

Males who have female partners that are able to become pregnant should also use effective birth control before and during treatment with ENVARSUS XR. Talk to your healthcare provider before starting treatment with ENVARSUS XR about birth control methods that may be right for you. There is a pregnancy registry for females who become pregnant and males who have fathered a pregnancy during treatment with ENVARSUS XR.

The purpose of this registry is to collect information about your health and of your baby. To enroll in this voluntary registry, call 1-877- 955-6877 or register at https://www.transplantpregnancyregistry.org . are breastfeeding or plan to breastfeed. ENVARSUS XR passes into your breast milk.

You and your healthcare provider should decide if you will breastfeed while taking ENVARSUS XR Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, natural, herbal or nutritional supplements. ENVARSUS XR may affect the way other medicines work, and other medicines may affect how ENVARSUS XR works. Especially tell your healthcare provider if you take: sirolimus (RAPAMUNE): everolimus cyclosporine (GENGRAF, NEORAL, and SANDIMMUNE) medicines called aminoglycosides that are used to treat bacterial infections ganciclovir (CYTOVENE IV, VALCYTE) amphotericin B (ABELCET, AMBISOME) cisplatin antiviral medicines called nu…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.