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Tacrolimus .5 mg Capsule, Extended Release

by Amneal Pharmaceuticals NY LLC · 1 BAG in 1 CARTON (69238-2780-3) / 3 BLISTER PACK in 1 BAG / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK

NDC 69238-2780-03

🏷️ FDA NDC (as labeled) 69238-2780-3 billing pads the package segment with a zero

Rx only Generic 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 Dr. Brian Staiger, PharmD

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) 69238-2780-3

Product NDC 69238-2780

11-digit billing NDC 69238278003

NCPDP billing unit EA — each (per item)

RxCUI 1431971, 1431980, 1431985

UNII WM0HAQ4WNM

UPC 0369238278231, 0369238278132, 0369238278033

Application # ANDA215012

SPL Set ID 4eb1b6bd-beec-4dd5-9a48-c93a9fe918b3

Established class (EPC) Calcineurin Inhibitor Immunosuppressant

Mechanism of action Calcineurin Inhibitors

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2026-03-02

Route ORAL

Dosage form CAPSULE, EXTENDED RELEASE

Substance TACROLIMUS

GPI-14 99404080007005

GCN Seq No 062896

GCN 98662

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 TACROLIMUS XL 0.5 MG CAPSULE

FDB brand name Tacrolimus Xl

Legend status F — Federal legend — prescription drug or device

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 69238-2780-3 — 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 → 69238-2780-03. 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

LabelerAmneal Pharmaceuticals NY LLC

Application holderCHENGDU SUNCADIA MEDICINE CO LTD

FDA applicationANDA215012 (ANDA)

Labeler code69238

First marketedMar 2026

Product typeHuman Prescription Drug

Portfolio372 products on file

🔎 All NDCs from Amneal Pharmaceuticals NY LLC

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 TACROLIMUS XL 0.5 MG CAPSULE 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 →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Tacrolimus — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Tacrolimus (202 interactions) — ranked by severity →

Nutrient depletion considerations

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

MAGNESIUM Major Depletion

🧪 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 pink / orange / yellow

ShapeCapsule

ImprintSD;TC;5;mg

Size21 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 7Z8S9VYZ4B
Ethylcellulose is a plant-derived thickener and film-former made by chemically modifying cellulose. It's used as a binder to hold tablet ingredients together, a coating to control how quickly medicine is released, or a thickener in liquid formulations.
UNII 1K09F3G675
Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
UNII EX438O2MRT
Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
UNII 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
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 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

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 system	Per each	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.

ℹ️

No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.

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.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Astagraf Xl .5 mg 00469-0647-11	Astellas	10 capsules	—	AB	Discontinued	—
Tacrolimus .5 mgthis 69238-2780-03	Amneal	10 capsules	—	AB	FDA listed	—
tacrolimus .5 mg 71432-2001-01	Chengdu	10 capsules	—	AB	FDA listed	—

About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.

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

🏛️

2026

On the market since

Mar 2026

📍

2026

Currently FDA-listed

listed with the FDA

🔓

Generic on the market

this product is a generic

✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

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

Medicare Part D (outpatient prescription) spending for Tacrolimus — the program that covers self-administered drugs. 16 manufacturers.

⚠️ 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 Tacrolimus. 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

$21.27M

Claims incl. refills

205.6K

Beneficiaries

143K

Spend / beneficiary

$148.76

Spend / claim

$103.47

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

Reporter sex

Serious outcomes

Death25,785

Disabling2,296

Reports over time (by year) — tap or hover for the count & year

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 NDC	Description	Marketing start	Status
69238-2780-03 You're viewing this	1 BAG in 1 CARTON (69238-2780-3) / 3 BLISTER PACK in 1 BAG / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK	2026-03-02	Active

🧭 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	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“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 69238-2780-3, 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: 69238-2780-03, written without dashes as 69238278003. 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 69238-2780-03, the first segment (69238) is the labeler code FDA assigned to Amneal Pharmaceuticals NY LLC; the middle segment (2780) 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 Amneal Pharmaceuticals NY LLC. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

Amneal Pharmaceuticals NY LLC 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.

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 147 words ▾

WARNING: MALIGNANCIES AND SERIOUS INFECTIONS IN TRANSPLANT PATIENTS; AND INCREASED MORTALITY IN FEMALE LIVER TRANSPLANT PATIENTS Increased risk for developing serious infections and malignancies with tacrolimus extended-release capsules or other immunosuppressants that may lead to hospitalization or death. [see Warnings and Precautions ( 5.1 , 5.2 )] Increased mortality in female liver transplant patients with tacrolimus extended-release capsules. Tacrolimus extended-release capsules is not approved for use in liver transplantation. [see Warnings and Precautions (5.3) ] WARNING: MALIGNANCIES AND SERIOUS INFECTIONS IN TRANSPLANT PATIENTS; AND INCREASED MORTALITY IN FEMALE LIVER TRANSPLANT PATIENTS See full prescribing information for complete boxed warning.

Increased risk for developing serious infections and malignancies with tacrolimus extended-release capsules or other immunosuppressants that may lead to hospitalization or death. ( 5.1 , 5.2 ) Increased mortality in female liver transplant patients with tacrolimus extended-release capsules. Not approved for use in liver transplantation.

( 5.3 )

🎯 Indications and Usage 88 words ▾

1 INDICATIONS AND USAGE Tacrolimus extended-release capsules is indicated for the prophylaxis of organ rejection in kidney transplant patients in combination with other immunosuppressants in adult and pediatric patients who can swallow capsules intact [see Use in Specific Populations (8.4) and Clinical Studies (14.1), (14.2)] . Tacrolimus extended-release capsules is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in kidney transplant patients in combination with other immunosuppressants in adult and pediatric patients who can swallow capsules intact.

( 1 , 8.4 , 14.1 , 14.2 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Capsules must be taken whole. ( 2.1 ) Take consistently every morning at the same time on an empty stomach at least 1 hour before a meal or at least 2 hours after a meal. ( 2.1 ) Avoid eating grapefruit or drinking grapefruit juice or alcohol.

( 2.1 ) African-American patients and patients with severe hepatic impairment may require dosing adjustments. ( 2.3 ) Frequent monitoring of trough concentrations is recommended. ( 2.4 ) For complete dosing information, see Full Prescribing Information.

Recommended Tacrolimus Extended-Release Capsules Initial Dosage Patient Population Initial Oral Dosage Whole Blood Trough Concentration Range ADULT With basiliximab, MMF and steroids 0.15 mg/kg to 0.2 mg/kg once daily prior to reperfusion or within 48 hours of completion of transplant Month 1: 7 ng/mL to 15 ng/mL Month 2 to Month 6: 5ng/mL to 15 ng/mL More than 6 Months: 5 ng/mL to 10ng/mL With MMF and steroids, without basiliximab induction First dose (pre-operative): 0.1mg/kg, within 12 hours prior to reperfusion Subsequent doses (post-operative): 0.2mg/kg once daily at least 4 hours after pre-operative dose and within 12 hours after reperfusion Month 1: 10 ng/mL to 15 ng/mL Month 2 to Month 6: 5ng/mL to 15 ng/mL More than 6 Months: 5 ng/mL to 10 ng/mL PEDIATRIC With basiliximab, MMF and steroids 0.3 mg/kg once daily, administered within 24 hours following reperfusion Month 1: 10 ng/mL to 20 ng/mL More than Month 1: 5 ng/mL to 15 ng/mL MMF = Mycophenolate mofetil

2.1Important Administration Instructions Tacrolimus extended-release capsules should not be used without the supervision by a physician with experience in immunosuppressive therapy. Tacrolimus extended-release capsules is not interchangeable or substitutable for tacrolimus extended-release tablets, tacrolimus immediate-release capsules or tacrolimus for oral suspension. Under or overexposure to tacrolimus may result in graft rejection or other serious adverse reactions.

Changes between tacrolimus immediate-release and extended-release dosage forms must occur under physician supervision [see Warnings and Precautions (5.4) ]. Advise patients to swallow tacrolimus extended-release capsules whole with liquid; patients must not chew, divide, or crush the capsules. Tacrolimus extended-release capsules should be taken consistently every morning at the same time to ensure consistent and maximum possible drug exposure, on an empty stomach at least 1 hour before a meal, or at least 2 hours after a meal [see Clinical Pharmacology (12.3) ] .

If a dose is missed, the dose may be taken up to 14 hours after the scheduled time (i.e., for a missed 8:00 AM dose, a dose may be taken by 10:00 PM). Beyond the 14-hour time frame, the patient should wait until the usual scheduled time the following morning to take the next regular daily dose. Instruct the patient not to double the next dose.

Advise patients to avoid eating grapefruit or drinking grapefruit juice or alcoholic beverages while taking tacrolimus extended-release capsules [see Drug Interactions (7.2) ] . Therapeutic drug monitoring is recommended for all patients receiving tacrolimus extended-release capsules [see Dosage and Administration (2.4) ] .

2.2Dosage Recommendations for Kidney Transplant Patients Table 1 includes the recommended starting tacrolimus extended-release capsules dosages and whole blood trough concentration ranges; the observed trough concentrations are shown in another section of the Full Prescribing Information [see Clinical Studies (14) ]. Titrate the tacrolimus extended-release capsules dosage based on clinical assessments of rejection and tolerability, and to achieve target trough concentration ranges [see Dosage and Administration (2.4) and Warnings and Precautions ( 5.6 , 5.7 , 5.10 , 5.11 )].

Table 1: Recommended Starting Daily Dosage Regimen of Tacrolimus Extended-Release Capsules Recommended Tacrolimus Extended-Release Capsules Initial Dosage * Patient Population Initial Oral Dos…

💊 Dosage Forms and Strengths 100 words ▾

3 DOSAGE FORMS AND STRENGTHS Tacrolimus extended-release capsules: 0.5 mg: opaque yellowish pink cap and opaque light orange body branded with dull red “SD-TC”on the capsule body and dull red “0.5 mg” on the capsule cap. 1 mg: opaque light yellow cap and opaque light orange body branded with dull red “SD-TC”on the capsule body and dull red “1 mg” on the capsule cap. 5 mg: opaque red-orange cap and opaque orange body branded with dull red “SD-TC”on the capsule body and dull red “5 mg” on the capsule cap.

Capsules: 0.5 mg, 1 mg, 5 mg ( 3 )

⛔ Contraindications 27 words ▾

4 CONTRAINDICATIONS Tacrolimus extended-release capsules is contraindicated in patients with known hypersensitivity to tacrolimus [see Adverse Reactions (6.2) ] . Known hypersensitivity to tacrolimus. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Not Interchangeable with Other Tacrolimus Products-Medication Errors: Instruct patients or caregivers to recognize the appearance of tacrolimusextended-release capsules. ( 5.4 ) New onset diabetes after transplant: Monitor blood glucose. ( 5.5 ) Nephrotoxicity (acute and/or chronic): May occur due to tacrolimus extended-release capsules, drug interactions, concomitant nephrotoxic drugs.

Monitor renal function; consider dosage reduction. ( 5.6 ) Neurotoxicity: Including risk of posterior reversible encephalopathy syndrome (PRES), monitor for neurologic abnormalities; reduce dosage or discontinue tacrolimus extended-release capsules. ( 5.7 ) Hyperkalemia: Risk may be increased with other agents associated with hyperkalemia; monitor serum potassium levels.

( 5.8 ) Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. ( 5.9 ) QT prolongation: Consider obtaining electrocardiograms and monitoring electrolytes in patients at high risk. ( 5.11 ) Immunizations: Avoid live vaccines.

( 5.12 ) Pure red cell aplasia: Consider discontinuation of tacrolimus extended-release capsules. ( 5.13 ) 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 tacrolimus extended-release capsules, 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 broad-spectrum 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 patients who are EBV seronegative, a population which includes many young children. Monitor EBV serology during treatment.

5.2Serious Infections Immunosuppressants, including tacrolimus extended-release capsules, 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) 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 , 6.2 )] .

5.3Increased Mortality in Female Liver Transplant Patients In a clinical trial of 471 liver transplant patients randomized to tacrolimus extended-release capsules or tacrolimus immediate-release product, mortality at 12 months was 10% higher among the 76 female patients (18%) treated with tacrolimus extended-release capsules compared to the 64 female patients (8%) treated with tacrolimus immediate-release product. Tacrolimus extended-release capsules is not approved for the prophylaxis of organ rejection in patients who received a liver transplant.

5.4Not Interchangeable with Other Tacrolimus Products - Medication Errors Medication errors, including substitution and dispensing errors, between tacrolimus immediate-release products 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. Tacrolimus extended-release ca…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse drug reactions are discussed in greater detail in other sections of labeling: Lymphoma and Other Malignancies [see Warnings and Precautions (5.1) ] Serious Infections [see Warnings and Precautions (5.2) ] Increased Mortality in Female Liver Transplant Patients [see Warnings and Precautions (5.3) ] New Onset Diabetes after Transplant [see Warnings and Precautions (5.5) ] Nephrotoxicity due to Tacrolimus Extended-Release Capsules and Drug Interactions [see Warnings and Precautions (5.6) ] Neurotoxicity [see Warnings and Precautions (5.7) ] Hyperkalemia [see Warnings and Precautions (5.8) ] Hypertension [see Warnings and Precautions (5.9) ] QT Prolongation [see Warnings and Precautions (5.11) ] Pure Red Cell Aplasia [see Warnings and Precautions (5.13) ] Thrombotic Microangiopathy, Including Hemolytic Uremic Syndrome and Thrombotic Thrombocytopenic Purpura [see Warnings and Precautions (5.14) ] The most common adverse reactions (≥ 30%) are: diarrhea, constipation, nausea, peripheral edema, tremor and anemia.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In addition, the clinical trials were not designed to establish comparative differences across study arms with regards to the adverse reactions discussed below. Kidney transplant patients were treated with tacrolimus extended-release capsules (N=214) or tacrolimus immediate- release product (N=212) and concomitant immunosuppressants (median duration of exposure of 12 months) in a randomized, open-label, active-controlled trial of mostly U.S. patients (Study 1) [see Clinical Studies (14.1) ] .

The types of adverse reactions seen in Study 1 were similar to the adverse reactions seen in Study 2 [non-U.S. trial in kidney transplant patients treated with tacrolimus extended-release capsules (N=331) or tacrolimus immediate-release product (N=336) and concomitant immunosuppressants] [see Clinical Studies (14.2) ] . In Study 1, the proportion of patients who discontinued treatment due to adverse reactions was 9% and 11% in the tacrolimus extended-release capsules and tacrolimus immediate-release treatment groups, respectively, through 12 months of treatment.

The most common adverse reactions leading to discontinuation in tacrolimus extended-release capsules-treated patients were related to infections or renal/urinary disorders. Infections The overall incidence of infections, serious infections, and infections with identified etiology reported in patients treated with the tacrolimus extended-release capsules or tacrolimus immediate-release product in Study 1 are shown in Table 2 . Table 2: Percentage of Patients with Infections in Study 1 a Through One Year Post-Kidney Transplant Tacrolimus extended-release capsules, MMF, steroids, basiliximab induction N=214 Tacrolimus immediate-release product, MMF, steroids, basiliximab induction N=212 All Infections 69% 69% Respiratory Infections 34% 31% Urinary Tract Infections 16% 25% Cytomegalovirus Infections 10% 11% Bacterial Infections 8% 12% Gastroenteritis 7% 3% Polyomavirus Infections 3% 5% Serious Infections 22% 23% a Study 1 was not designed to support comparative claims of tacrolimus extended-release capsules compared to tacrolimus immediate-release product for the adverse reactions reported in this table.

New Onset Diabetes After Transplant (NODAT) The incidence of new onset diabetes after transplantation (defined by the composite occurrence of ≥ 2 fasting plasma glucose values that were more than 126 mg/dL at ≥ 30 days apart, insulin use for≥ 30 consecutive days, oral hypoglycemic use…

🔄 Drug Interactions ~2 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 , 5.10 , 7.2 ) Therapeutic drug monitoring and dose reduction for tacrolimus extended-release capsules should be considered when tacrolimus extended-release capsules is co-administered with cannabidiol. ( 2.4 , 5.15 , 7.3 ) See Full Prescribing Information for clinically significant drug interactions.

( 7.1 , 7.2 , 7.3 )

7.1Mycophenolic Acid When tacrolimus extended-release capsules is prescribed with a given dose of a mycophenolic acid (MPA) product, exposure to MPA is higher with tacrolimus extended-release capsules 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 mycophenolic acid products as needed.

7.2Effects of Other Drugs on Tacrolimus Extended-Release Capsules Table 5 displays the effects of other drugs on tacrolimus extended-release capsules. Table 5: Effects of Other Drugs/Substances on Tacrolimus Extended-Release Capsules a 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 ( 5.7 , 5.10 , 5.11 )].

Avoid grapefruit or grapefruit juice. Alcohol May increase the rate of tacrolimus release and increase the risk of serious adverse reactions (e.g., neurotoxicity, QT prolongation ) [see Warnings and Precautions ( 5.7 , 5.10 , 5.11 )]. Avoid alcoholic beverages.

Strong CYP3A Inducers c : 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 (5.10) ]. Increase tacrolimus extended-release capsules dose and monitor tacrolimus whole blood trough concentrations [see Dosage and Administration ( 2.3 , 2.4 ) and Clinical Pharmacology (12.3) ]. Strong CYP3A Inhibitors c : Protease inhibitors (e.g., nelfinavir, telaprevir, boceprevir, ritonavir), azole antifungals (e.g., voriconazole, posaconazole, itraconazole, ketoconazole), antibiotics (e.g., clarithromycin, troleandomycin, chloramphenicol), nefazodone, letermovir, Schisandra sphenanthera extracts 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 ( 5.7 , 5.10 , 5.11 )]. Reduce tacrolimus extended-release capsules 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 ( 2.3 , 2.4 ) 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 ( 5.10 )] Mild or Moderate CYP3A Inhibitors: Clotrimazole, antibiotics (e.g., verapamil, diltiazem, nifedipine, nicardipine), amiodarone, danazol, ethinyl estradiol, cimetidine, lansoprazole and omeprazole May increase tacrolimus whole blood trough concentrations and increase the risk of serious adverse reactions (e.g., neurotoxicity, QT prolongation) [see Warnings and Precautions ( 5.7 , 5.10 , 5.11 )].

Monitor tacrolimus whole blood trough concentrations and reduce tacrolimus extended-release capsules dose if needed [see Dosage and Administration ( 2.3 , 2.4 ) and Clinical Pharmacology (12.3) ]. Other drugs, such as: Magnesium and a…

👥 Use in Specific Populations ~2 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 tacrolimus extended-release capsules 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 [0.5 the maximum recommended clinical dose (0.2 mg/kg/day), on a mg/m 2 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 (0.8 the maximum recommended clinical dose, on a mg/m 2 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 (0.8 times the maximum recommended clinical dose, on a mg/m 2 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 Tacrolimus extended-release capsules may increase hyperglycemia in pregnant women with diabetes (including gestational diabetes). Monitor maternal blood glucose levels regularly [see Warnings and Precautions (5.5) ] .

Tacrolimus extended-release capsules may exacerbate hypertension in pregnant women and increase pre-eclampsia. Monitor and control blood pressure [see Warnings and Precautions ( 5.8 , 5.9 )] . 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 tacrolimus extended-release capsules.

Labor or Delivery There is an increased risk for premature del…

🤰 Pregnancy ~2 min read ▾

Labor or Delivery There is an increased risk for premature delivery (less than 37 weeks) following transplantation and maternal exposure to tacrolimus extended-release capsules. Data Human Data The…

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use The safety and effectiveness of tacrolimus extended-release capsules in de novo pediatric kidney transplant patients have been established. Use of tacrolimus extended-release capsules in pediatric kidney transplant patients is based on adequate and well-controlled studies of tacrolimus extended-release capsules in adult kidney transplant patients [see Clinical Studies ( 14.1 , 14.2 )] and supported by pharmacokinetic and safety data of tacrolimus extended-release capsules in pediatric transplant patients 4 years of age and older who are able to swallow capsules intact and Prograf (tacrolimus) capsules in adult and pediatric transplant patients [see Clinical Pharmacology (12.3) ].

De Novo Pediatric Kidney Transplant Patients A pharmacokinetic and safety study included 25 de novo pediatric kidney transplant patients, 4 to 15 years of age, randomized to Prograf (N=12) or tacrolimus extended-release capsules (N=13). Tacrolimus exposures for the two drug products were comparable on Day 7 and Day 28 [see Clinical Pharmacology (12.3) ]. Among the 13 pediatric kidney transplant patients who completed 52 weeks on tacrolimus extended-release capsules, there were no graft loss, deaths or episodes of biopsy-proven acute rejection [see Dosage and Administration (2.2) and Adverse Reactions (6.1) ].

Stable Pediatric Kidney Transplant Patients Another pharmacokinetic and safety study included 48 stable pediatric kidney transplant patients, 5 to 16 years of age, who were converted from a Prograf-based regimen to tacrolimus extended-release capsules. Tacrolimus systemic exposures for the two drug products were comparable [see Clinical Pharmacology (12.3) ]. Acute rejections were reported in 2/48 kidney pediatric patients that responded to subsequent treatment.

There were no graft failures or deaths following use of tacrolimus extended-release capsules during the 54-week follow up [see Adverse Reactions (6.1) ].

🧓 Geriatric Use 115 words ▾

8.5Geriatric Use Clinical studies of tacrolimus extended-release capsules did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. In Studies 1 and 2, 29 patients were 65 years of age and older, and 3 patients were 75 years of age and over [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 139 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) 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 (a ubiquitous mammalian intracellular enzyme) is then formed and the phosphatase activity of calcineurin is 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 7 summarizes the pharmacokinetic (PK) parameters of tacrolimus following oral administration of tacrolimus extended-release capsules in healthy subjects and in kidney transplant patients. Whole blood tacrolimus concentrations in these PK studies were measured using validated HPLC/MS/MS assays. Table 7: Pharmacokinetic Parameters of Tacrolimus Extended-Release Capsules (Given Once Daily) in Healthy Subjects and in Kidney Transplant Patients (Under Fasted Conditions) Population Tacrolimus Extended-Release Capsules Dose a Day b PK Parameters of Tacrolimus Extended-Release Capsules C max c (ng/mL) T max d (hr) AUC 24 c (ng•hr/mL) C 24 f (ng/mL) Healthy Subjects (N=24) 4 mg 4 mg Day 1 Day 10 6.2 ± 2.1 11.6 ± 3.4 2 [1 to 5] 2 [1 to 3] 74 ± 22 155 ± 46 2.3 ± 0.8 4.7 ±

1.5Adult Kidney De novo e (N=17) 0.2 mg/kg 0.19 mg/kg 0.18 mg/kg 0.18 mg/kg Day 1 Day 3 Day 7 Day 14 26 ± 13.7 31 ± 13.9 32.2 ± 10.2 32.7 ± 9 3 [2 to 24] 2 [0.5 to 2] 2 [1 to 6] 2 [1 to 4] 372 ± 202 437 ± 175 405 ± 117 412 ± 109 12.1 ± 7.2 13.5 ± 5.6 11.4 ± 4 11.2 ±

3.9Adult Kidney (6 months or greater post-transplant) (N=60) 5.2 mg/day g Day 14 g 16.1 ± 5.3 2 [1 to 6] 222 ± 64 6.7 ± 1.9 h a Healthy adult subjects (actual administered dose of tacrolimus extended-release capsules); adult de novo kidney transplant patients (actual group mean dose of tacrolimus extended-release capsules). b Day of tacrolimus extended-release capsules treatment and PK profiling. c Arithmetic means ± S.D. d Median [range]. e “ De novo ” refers to immunosuppression starting at the time of transplantation; data from PK substudy of Study 2. f Tacrolimus trough concentration before the next dose. g Same daily dose of tacrolimus extended-release capsules for 14-day period. h Correlation coefficient of AUC 24 to C min r = 0.88.

In de novo adult kidney transplant patients, the tacrolimus systemic exposure, as assessed by AUC 24 , for tacrolimus extended-release capsules 0.2 mg/kg once daily on Day 1 post-transplant was 18% (Ratio [SD]: 0.822 [1.647]) lower when compared with Prograf (tacrolimus immediate-release) 0.2 mg/kg/day given twice daily. By Day 3 post-transplant, the AUC 24 was similar between the two formulations. On Day 14 (steady state), the AUC 24 for tacrolimus extended-release capsules was 21% (Ratio [SD]: 1.207 [1.326]) higher than that of Prograf (tacrolimus immediate-release), at comparable trough concentrations (C 24 ).

Due to intersubject variability in tacrolimus PK, individualization of dosing regimen is necessary for optimal therapy [see Dosage and Administration ( 2.3 , 2.4 )] . Pharmacokinetic data indicate that whole blood concentrations rather than plasma concentrations serve as the more appropriate sampling compartment to describe tacrolimus PK. Absorption In healthy subjects, the administration of escalating tacrolimus extended-release capsules doses…

🧬 Mechanism of Action 137 words ▾

📦 How Supplied / Storage and Handling 200 words ▾

16 HOW SUPPLIED Tacrolimus extended-release capsules are supplied as listed in Table 19 . Table 19: Strengths of Tacrolimus Extended-Release Capsules 0.5 mg Oblong capsule with opaque yellowish pink cap and opaque light orange body. Capsule is branded with dull red “SD-TC” on capsule body and dull red “0.5 mg” on the capsule cap.

Blister carton packed with an aluminum foil bag containing 3 blister cards of 10 capsules on each card. (NDC 69238-2780-3). 1 mg Oblong capsule with opaque light yellow cap and opaque light orange body.

Capsule is branded with dull red “SD-TC” on capsule body and dull red “1 mg” on the capsule cap. Blister carton packed with an aluminum foil bag containing 3 blister cards of 10 capsules on each card. (NDC 69238-2781-3) 5 mg Oblong capsule with an opaque red-orange cap and opaque orange body.

Capsule is branded with dull red “SD-TC” on capsule body and dull red “5 mg” on the capsule cap. Blister carton packed with an aluminum foil bag containing 3 blister cards of 10 capsules on each card. (NDC 69238-2782-3) Store and Dispense Store at 25°C (77°F); excursions permitted from 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

📋 Description ~1 min read ▾

11 DESCRIPTION Tacrolimus is the active ingredient in tacrolimus extended-release capsules. 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.

Tacrolimus extended-release capsules is available for oral administration as hard gelatin capsules containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus, USP. Inactive ingredients include ethylcellulose NF, hypromellose USP, magnesium stearate NF and lactose monohydrate NF. The ingredients are directly proportional across all capsule strengths.

The capsule shell contains gelatin NF, ferric oxide red NF, ferric oxide yellow NF, and titanium dioxide USP. chem 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 or caregivers to: Inspect their tacrolimus extended-release capsules medicine when they receive a new prescription and before taking it. If the appearance of the capsule 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 they have the right medicine. Other tacrolimus products cannot be substituted for tacrolimus extended-release capsules [see Warnings and Precautions (5.4)] .

Take tacrolimus extended-release capsules at the same time every day to achieve consistent blood concentrations. Take tacrolimus extended-release capsules in the morning, on an empty stomach at least 1 hour before or at least 2 hours after breakfast, to achieve maximum possible blood concentrations of the drug. Swallow capsule whole with liquid.

Do not chew, divide or crush capsule. Avoid alcoholic beverages, grapefruit, and grapefruit juice while on tacrolimus extended-release capsules [see Dosage and Administration (2.1) and Drug Interactions (7.2) ] . Take a missed dose of tacrolimus extended-release capsules as soon as possible but not more than 14 hours after the scheduled time (i.e., for a missed 8 AM dose, take by 10 PM).

Beyond the 14-hour timeframe, instruct the patient to wait until the usual scheduled time the following morning to take the next scheduled dose. Do not take 2 doses at the same time.

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 using a broad spectrum sunscreen with a high protection factor [see 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 of the skin [see Boxed Warning and Warnings and Precautions (5.2) ] .

17.4New Onset Diabetes after Transplant Inform patients that tacrolimus extended-release capsules 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 (5.5) ] .

17.5Nephrotoxicity Inform patients that tacrolimus extended-release capsules 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 (5.6) ] .

17.6Neurotoxicity Inform patients that they are at risk of developing adverse neurologic reactions 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 (5.7) ] .

17.7Hyperkalemia Inform patients that tacrolimus extended-release capsules 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 (5.8) ] .

17.8Hypertension Inform patients that tacrolimus extended-release capsules can cause high blood pressure which may require treatment with anti-hypertensive therapy [see Warnings and Precautions (5.9) ] . Advise patients to monitor their blood pressure.

17.9Thrombotic Microangiopathy Inform patients that tacrolimus extended-release capsules can cause blood clotting problems. The risk of this occurring increases when patients take tacrolimus extended-release capsules and sirolimu…

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Tacrolimus [ta-KROE-li-mus] Extended-Release Capsules Read this Medication Guide before you start taking tacrolimus extended-release capsules 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 tacrolimus extended-release capsules, ask your healthcare provider or pharmacist. What is the most important information I should know about tacrolimus extended-release capsules? Tacrolimus extended-release capsules can cause serious side effects, including: Increased risk of cancer.

People who take tacrolimus extended-release capsules have an increased risk of getting some kinds of cancer, including skin and lymph gland cancer (lymphoma). Increased risk of infection. Tacrolimus extended-release capsules is a medicine that affects your immune system.

Tacrolimus extended-release capsules can lower the ability of your immune system to fight infections. Serious infections can happen in people receiving tacrolimus extended-release capsules 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 Increased risk of death in females who have had a liver transplant.

You should not take tacrolimus extended-release capsules if you have had a liver transplant without talking to your healthcare provider. What is tacrolimus extended-release capsules? Tacrolimus extended-release capsules is a prescription medicine used with other medicines to help prevent organ rejection in people who have had a kidney transplant.

Tacrolimus extended-release capsules is an extended-release capsule and is not the same as tacrolimus immediate-release capsules, tacrolimus for oral suspension or tacrolimus extended-release tablets. Your healthcare provider should decide what medicine is right for you. Who should not take tacrolimus extended-release capsules?

Do not take tacrolimus extended-release capsules if you are allergic to tacrolimus or any of the ingredients in tacrolimus extended-release capsules. See the end of this leaflet for a complete list of ingredients in tacrolimus extended-release capsules. What should I tell my healthcare provider before taking tacrolimus extended-release capsules?

Before you take tacrolimus extended-release capsules tell your healthcare provider 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 or any other medical conditions. are pregnant or plan to become pregnant. Tacrolimus extended-release capsules may harm your unborn baby.

If you are able to become pregnant, you should use effective birth control before and during treatment with tacrolimus extended-release capsules. Talk to your healthcare provider before starting treatment with tacrolimus extended-release capsules about birth control methods that may be right foryou. Males who have female partners that are able to become pregnant should also use effective birth control before and during treatment with tacrolimus extended-release capsules.

Talk to your healthcare provider before starting treatment with tacrolimus extended-release capsules 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 tacrolimus extended-release capsules. The purpose of this registry is to collect information about your health and of your baby.

To enroll in this voluntary registry, call 1-877955-6877 or go tohttps://www.transplantpregnancyregistry.org/. are breastfeeding or plan to breastfeed. Tacrolimus extended-release capsules passes into your breast milk. You and your healthcare provider should decide if you will…

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

immunosuppressant: A medicine that lowers the activity of the immune system.

immunosuppressive: Describes something that lowers the activity of the immune system.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

Active ingredient: The part of a medicine that produces its intended effect on the body.

active-controlled: Describes a study that compares a new medicine against another medicine already known to work, instead of a dummy pill.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

anemia: A low level of red blood cells or the oxygen-carrying protein inside them, which can cause tiredness, weakness, and paleness.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

Boxed Warning: The strongest safety warning the FDA can require, set inside a bold black border because the risk it describes can be very serious.

broad-spectrum: Describes an antibiotic that works against a wide range of different bacteria.

cholestasis: A slowing of bile flow out of the liver; bile is the fluid that helps digest fat, and this backup can cause itching and yellow skin.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

dose reduction: Lowering the amount of a medicine, often to ease side effects or fit a person's needs.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

edema: Swelling caused by extra fluid trapped in the body's tissues.

encephalopathy: Any condition that affects how the brain works, causing confusion, memory problems, or changes in alertness.

enterohepatic recirculation: A cycle where a medicine passes into the gut with bile, then is reabsorbed back into the blood.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

extended-release: A pill or capsule made to release its medicine slowly over many hours, so it can be taken less often; often labeled ER or XR.

fetal harm: Injury or damage to a developing baby while it is growing inside the womb.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

hyperglycemia: High blood sugar, meaning there is more glucose (sugar) in the blood than normal.

hyperkalemia: A higher-than-normal level of potassium, an important mineral, in the blood.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

immediate-release: A standard pill or capsule that releases all of its medicine soon after it is swallowed.

immunosuppression: A weakening of the body's defense system, which makes it harder to fight off infections.

in utero: Inside the womb, describing a baby before it is born.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

lactation: The making and release of milk from a mother's breasts after giving birth.

lethargy: A state of tiredness and sluggishness, often with slowed thinking or movement.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Medication Guide: An FDA-approved handout written for patients that explains important safety information about certain medicines in plain language.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

neonatal: Relating to a newborn baby during its first four weeks of life.

nephrotoxicity: Damage to the kidneys caused by a medicine or other substance.

open-label: A study in which both the patients and their doctors know which treatment each person is receiving.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

peripheral edema: Swelling, usually in the feet, ankles, or legs, caused by extra fluid building up in the tissues.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

postmarketing surveillance: Tracking of a medicine's safety after it is approved and being used by the general public.

postpartum: The period of time right after a woman gives birth.

Pregnancy Exposure Registry: A study that collects health information from women who took a medicine while pregnant to learn how safe it is.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

prophylaxis: Treatment given to prevent an infection or illness before it starts, rather than to treat one that is already present.

protein binding: How much of a medicine sticks to proteins in the blood instead of moving freely through the body.

purpura: Purple spots or patches on the skin caused by bleeding just under the surface.

QT prolongation: A longer-than-normal electrical recovery time between heartbeats, seen on a heart tracing (ECG), which can raise the chance of a dangerous heart rhythm.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

receptor: A special docking spot on a cell that a medicine or natural body chemical attaches to in order to trigger an effect.

seizure: A sudden burst of abnormal electrical activity in the brain that can cause shaking, staring, confusion, or loss of awareness.

serum creatinine: A waste product measured in a blood test; higher levels can mean the kidneys are not filtering as well as normal.

somnolence: Feeling very sleepy or drowsy, with trouble staying awake during the day.

steady state: The point where the amount of medicine going in equals the amount leaving, so blood levels stay fairly even.

suspension: A liquid holding fine drug particles that are mixed in but not fully dissolved, so it must be shaken before use.

therapeutic drug monitoring: Measuring the amount of a medicine in the blood to keep it in a safe and effective range.

tremor: Shaking or trembling of part of the body, such as the hands, that a person cannot control.

trough: The lowest level a medicine reaches in the blood, just before the next dose is due.

urticaria: Raised, itchy welts on the skin, commonly called hives.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

← 69238-2733-01 · Amneal 69238-2781-03 · Amneal →

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.

Tacrolimus .5 mg Capsule, Extended Release

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