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SOVUNA Hydroxychloroquine Sulfate 200 mg Tablet, Film Coated, 30-count — NDC 70954-0804-10 package photo

SOVUNA Hydroxychloroquine Sulfate 200 mg Tablet, Film Coated, 30-count

by ANI Pharmaceuticals, Inc. · 30 TABLET, FILM COATED in 1 BOTTLE (70954-804-10)
NDC 70954-0804-10
🏷️ FDA NDC (as labeled) 70954-804-10 billing pads the product segment with a zero
This package
Contains30-count Pack sizes3 compare ↓
Also comes in: 14 tablets 70954-0804-30 100 tablets 70954-0804-20
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

🆔 Identity & classification

FDA NDC (as labeled) 70954-804-10
Product NDC 70954-804
11-digit billing NDC 70954080410
RxCUI 979092, 2569283, 2665282, 2665284
UNII 8Q2869CNVH
UPC 0370954805106, 0370954804208, 0370954804109
Application # NDA214581
SPL Set ID dd441154-b196-4d4c-bc56-2e37f345ef8d
Established class (EPC) Antimalarial; Antirheumatic Agent
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-09-15
Route ORAL
Dosage form TABLET, FILM COATED
Substance HYDROXYCHLOROQUINE SULFATE
GPI-14 13000020100305
GCN Seq No 009580
GCN 42940
HICL code 004151
Ingredient (HICL) Hydroxychloroquine Sulfate
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W4
Therapeutic class — intermediate (HIC2) Antiparasitics
HIC3 code W4A
Therapeutic class — specific (HIC3) Antimalarial Drugs
AHFS code 08:30.08.00
AHFS class Antimalarials
FDB label name SOVUNA 200 MG TABLET
FDB brand name Sovuna
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 70954-804-10 — a 5-3-2 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 product segment → 70954-0804-10. 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 Antimalarial class.

Pharmacologic class Antimalarial, Antirheumatic Agent
Drug family (ATC) Aminoquinolines
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

LabelerANI Pharmaceuticals, Inc.
Application holderNOVITIUM PHARMA LLC
FDA applicationNDA214581 (NDA)
Labeler code70954
First marketedSep 2023
Product typeHuman Prescription Drug
Portfolio299 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 SOVUNA 200 MG TABLET Ingredient Hydroxychloroquine Sulfate
📖 What it is MedlinePlus · NLM

Hydroxychloroquine is used to prevent and treat acute attacks of malaria in adults and children weighing more than 31 kg (68 lbs). It is also used to treat discoid lupus erythematosus (DLE; a chronic inflammatory condition of the skin) or systemic lupus erythematosus (SLE or lupus; an autoimmune disease in which the immune system attacks healthy parts of the body such as joints, skin, blood vessels, and organs) and rheumatoid arthritis. Hydroxychloroquine is in a class of drugs called antimalarials and is also an antirheumatic drug. It works by killing the organisms that cause malaria. Hydroxy...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It has two main uses. First, it treats and helps prevent malaria — a parasitic infection spread by mosquitoes — in both adults and children. Second, it helps manage autoimmune cond...
  • What exactly is hydroxychloroquine used for?
  • Always take it by mouth with food or milk — this helps protect your stomach and reduces nausea. Don't crush or split the tablet unless your specific product allows it; check your l...
  • How should I take my hydroxychloroquine tablet?
📖 Read our full Hydroxychloroquine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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
ShapeCapsule
Imprint171
Size15 mm
ScoringScored — splits in 2
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 M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • 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 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • 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.
  • UNII XHX3C3X673
    Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

12 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 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.
Try another pack size: 14 tablets 100 tablets
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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Hydroxychloroquine Sulfate 200 mg 00093-2401-01 Teva 100 tablets $0.149 AB Availability likely —
Hydroxychloroquine Sulfate 200 mg 00904-7046-06 Major 50 tablets $0.149 AB Availability likely —
Hydroxychloroquine Sulfate 200 mg 16571-0112-01 Rising 100 tablets $0.149 AB Availability likely —
Hydroxychloroquine sulfate 200 mg 16714-0110-01 Northstar 100 tablets $0.149 AB Availability likely —
Hydroxychloroquine Sulfate 200 mg 16729-0485-01 Accord 100 tablets $0.149 AB Availability likely —
Hydroxychloroquine Sulfate 200 mg 43598-0721-01 Dr. 100 tablets $0.149 AB Availability likely —
Hydroxychloroquine Sulfate 200 mg 50268-0412-15 AvPAK 50 tablets $0.149 AB Availability likely —
Hydroxychloroquine Sulfate 200 mg 59651-0889-01 Aurobindo 100 tablets $0.149 AB Availability likely —
Hydroxychloroquine 200 mg 62135-0752-90 Chartwell 90 tablets $0.149 AB Availability likely —
Hydroxychloroquine Sulfate 200 mg 68084-0269-01 American 1 tablet $0.149 AB Availability likely —
Hydroxychloroquine sulfate 200 mg 68382-0096-01 Zydus 100 tablets $0.149 AB Availability likely —
Hydroxychloroquine Sulfate 200 mg 69238-1544-01 Amneal 100 tablets $0.149 AB Availability likely —
Hydroxychloroquine sulfate 200 mg 82009-0045-05 Quallent 500 tablets $0.149 AB Availability likely —
Hydroxychloroquine Sulfate 200 mg 83980-0001-01 Ipca 100 tablets $0.149 AB Availability likely —
Hydroxychloroquine sulfate 200 mg 57664-0761-13 Sun 500 tablets $0.176 AB FDA listed —
Hydroxychloroquine sulfate 200 mg 00615-8459-39 NCS 30 tablets — AB FDA listed —
Hydroxychloroquine Sulfate 200 mg 42385-0971-01 Laurus 100 tablets — AB FDA listed —
Hydroxychloroquine Sulfate 200 mg 50090-4659-01 A-S 60 tablets — AB Discontinued —
Hydroxychloroquine sulfate 200 mg 50090-5573-00 A-S 30 tablets — AB Discontinued —
Hydroxychloroquine Sulfate 200 mg 50090-6280-01 A-S 60 tablets — AB FDA listed —
Hydroxychloroquine sulfate 200 mg 50090-6629-00 A-S 90 tablets — AB FDA listed —
Hydroxychloroquine sulfate 200 mg 50090-7306-01 A-S 60 tablets — AB FDA listed —
Hydroxychloroquine sulfate 200 mg 50090-7307-00 A-S 90 tablets — AB FDA listed —
Hydroxychloroquine sulfate 200 mg 55154-2074-00 Cardinal 1 tablet — AB FDA listed —
Hydroxychloroquine Sulfate 200 mg 55154-3567-00 Cardinal 10 tablets — AB FDA listed —
Plaquenil 200 mg 59212-0562-10 Advanz 100 tablets — AB FDA listed —
Hydroxychloroquine Sulfate 200 mg 60219-1544-01 Amneal 100 tablets — AB FDA listed —
Hydroxychloroquine sulfate 200 mg 65841-0633-01 Zydus 100 tablets — AB FDA listed —
Hydroxychloroquine Sulfate 200 mg 67046-1523-03 Coupler 30 tablets — AB FDA listed —
Hydroxychloroquine sulfate 200 mg 68071-2332-01 NuCare 100 tablets — AB FDA listed —
Hydroxychloroquine sulfate 200 mg 68071-3955-06 NuCare 60 tablets — AB FDA listed —
Hydroxychloroquine sulfate 200 mg 68788-7747-02 Preferred 20 tablets — AB FDA listed —
Sovuna 200 mgthis 70954-0804-10 ANI 30 tablets — — FDA listed —
Plaquenil 200 mg 71205-0448-12 Proficient 12 tablets — AB FDA listed —
Hydroxychloroquine sulfate 200 mg 71335-0897-01 Bryant 100 tablets — AB FDA listed —
Hydroxychloroquine Sulfate 200 mg 71335-1523-01 Bryant 100 tablets — AB FDA listed —
Hydroxychloroquine Sulfate 200 mg 71335-1771-01 Bryant 100 tablets — AB FDA listed —
Hydroxychloroquine Sulfate 200 mg 71335-2813-01 Bryant 100 tablets — AB FDA listed —
Hydroxychloroquine Sulfate 200 mg 71335-2814-01 Bryant 500 tablets — AB FDA listed —
Hydroxychloroquine Sulfate 200 mg 71335-3079-01 Bryant 100 tablets — AB FDA listed —
Hydroxychloroquine Sulfate 200 mg 71335-3113-01 Bryant 100 tablets — AB FDA listed —
Hydroxychloroquine Sulfate 200 mg 71335-3142-01 Bryant 100 tablets — AB FDA listed —
Plaquenil 200 mg 71610-0473-30 Aphena 30 tablets — AB FDA listed —
Hydroxychloroquine sulfate 200 mg 71610-0506-30 Aphena 30 tablets — AB FDA listed —
Hydroxychloroquine Sulfate 200 mg 71610-0701-53 Aphena 60 tablets — AB FDA listed —
Hydroxychloroquine Sulfate 200 mg 71610-0961-30 Aphena 30 tablets — AB FDA listed —
Hydroxychloroquine Sulfate 200 mg 72162-2467-01 Bryant 100 tablets — AB FDA listed —
Hydroxychloroquine sulfate 200 mg 76420-0850-01 Asclemed 100 tablets — AB FDA listed —
Hydroxychloroquine Sulfate 200 mg 82619-0131-01 Creekwood 100 tablets — AB FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
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

🏛️
2023
On the market since
Sep 2023
📍
2026
Currently FDA-listed
3 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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 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 tablets70954-0804-20 209 Rx · $217,137
30 tablets this page70954-0804-10 No Medicaid data
14 tablets70954-0804-30 No Medicaid data
Drug total (last 4 qtrs): 209 Rx · 12,705 units · $217,137 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 Sovuna — 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 Sovuna. 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
$120.1K
Claims incl. refills
150
Beneficiaries
76
Spend / beneficiary
$1,580.45
Spend / claim
$800.76
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
70954-0804-10 You're viewing this 30 TABLET, FILM COATED in 1 BOTTLE (70954-804-10) 2023-09-15 Active
70954-0804-20 100 TABLET, FILM COATED in 1 BOTTLE (70954-804-20) 2023-09-15 Active
70954-0804-30 14 TABLET, FILM COATED in 1 BOTTLE (70954-804-30) 2023-09-15 Active

You're viewing one of 3 pack sizes for this product.

This pack shows little to no recent Medicaid volume — the 100 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 70954-0804-10?
NDC 70954-0804-10 is a 30-count package — 30 tablet, film coated in 1 bottle.
What is the difference between NDC 70954-0804-10 and NDC 70954-0804-30?
Both are SOVUNA Hydroxychloroquine Sulfate 200 mg Tablet, Film Coated — the drug itself is identical. NDC 70954-0804-10 is the 30-count package, while NDC 70954-0804-30 is the 14 tablets package.
What NDC number is used to bill for this package of SOVUNA Hydroxychloroquine Sulfate 200 mg Tablet, Film Coated?
Bill NDC 70954-0804-10 — the 11-digit billing format is 70954080410. 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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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 70954-804-10, 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: 70954-0804-10, written without dashes as 70954080410. 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 70954-0804-10, the first segment (70954) is the labeler code FDA assigned to ANI Pharmaceuticals, Inc.; the middle segment (0804) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (10) 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 ANI 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 2 other package presentations of this same product, including 14 tablets (70954-0804-30), 100 tablets (70954-0804-20). 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?
ANI 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.
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.
🎯 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
🎯 Indications and Usage ~2 min read ▾

1 INDICATIONS & USAGE SOVUNA is an antimalarial and antirheumatic indicated for the: Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivax in adult and pediatric patients. (1.1) Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. (1.1) Treatment of rheumatoid arthritis in adults.

(1.2) Treatment of systemic lupus erythematosus in adults. (1.3) Treatment of chronic discoid lupus erythematosus in adults. (1.4) Limitations of Use (1.1): SOVUNA is not recommended for the: Treatment of complicated malaria.

Treatment of chloroquine or hydroxychloroquine-resistant strains of Plasmodium species. Treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium species has not been identified. Prophylaxis of malaria in geographic areas where chloroquine resistance occurs.

Prevention of relapses of P. vivax or P. ovale because it is not active against the hypnozoite liver stage forms of these parasites. For radical cure of P. vivax and P. ovale infections, concomitant therapy with an 8-aminoquinoline drug is necessary.

1.1Malaria SOVUNA is indicated in adult and pediatric patients for the: Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium vivax, and Plasmodium ovale. Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported. Limitations of Use: SOVUNA is not recommended for: Treatment of complicated malaria.

Treatment of malaria by chloroquine or hydroxychloroquine-resistant strains of Plasmodium species [see Microbiology (12.4)]. Treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium species has not been identified. Prophylaxis of malaria in geographic areas where chloroquine resistance occurs.

Prevention of relapses of P. vivax or P. ovale because it is not active against the hypnozoite liver stage forms of these parasites. For radical cure of P. vivax and P. ovale infections, concomitant therapy with an 8-aminoquinoline drug is necessary [see Microbiology (12.4)]. For the most current information about drug resistance, refer to the latest recommendations from the Center for Disease Control and Prevention.

1

1.2Rheumatoid Arthritis SOVUNA is indicated for the treatment of acute and chronic rheumatoid arthritis in adults.

1.3Systemic Lupus Erythematosus SOVUNA is indicated for the treatment of systemic lupus erythematosus in adults.

1.4Chronic Discoid Lupus Erythematosus SOVUNA is indicated for the treatment of chronic discoid lupus erythematosus in adults.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE & ADMINISTRATION Malaria in Adult and Pediatric Patients (2.2): Prophylaxis: Begin weekly doses 2 weeks prior to travel to the endemic area, continue weekly doses while in the endemic area, and continue the weekly doses for 4 weeks after leaving the endemic area: Adults: 400 mg once a week Pediatric patients weighing greater than or equal to 23 kg: 6.5 mg/kg actual body weight up to 400 mg, once a week Treatment of Uncomplicated Malaria: See Full Prescribing Information (FPI) for complete dosing information.

Rheumatoid Arthritis in Adults (2.3): Initial dosage: 400 mg to 600 mg daily Chronic dosage: 200 mg, 300 mg or 400 mg once daily (or in two divided doses) Systemic Lupus Erythematosus in Adults (2.4): 200 mg, 300 mg or 400 mg once daily (or in two divided doses) Chronic Discoid Lupus Erythematosus in Adults (2.5): 200 mg or 400 mg once daily (or in two divided doses)

2.1Important Administration Instructions Administer SOVUNA orally with food or milk. Do not crush the tablets.

2.2Dosage for Malaria in Adult and Pediatric Patients SOVUNA is not recommended in pediatric patients less than 23 kg because the lowest possible dose of 150 mg (half of the scored 300 mg tablet) exceeds the recommended dose for these patients. Prophylaxis Treatment must start 2 weeks before travel to an endemic area. Advise the patient to take the prophylaxis dosage once a week, staring 2 weeks prior to travel to the endemic area, on the same day every week, continuing the same weekly dose while in the endemic area, and for 4 weeks after leaving the endemic area.

The recommended prophylaxis dosage is: Adult patients: 400 mg once a week Pediatric patients weighing greater than or equal to 23 kg: 6.5 mg/kg actual body weight (up to 400 mg) once a week Treatment of Uncomplicated Malaria The dosages for the treatment of uncomplicated malaria are: Adult patients: Administer 800 mg initially; subsequently administer 400 mg at 6 hours, 24 hours, and 48 hours after the initial dose (total dosage = 2,000 mg). Pediatric patients weighing greater than or equal to 23 kg: Administer 13 mg/kg (up to 800 mg) initially; subsequently administer 6.5 mg/kg (up to 400 mg) at 6 hours, 24 hours, and 48 hours after the initial dose (total dosage = 31 mg/kg - up to 2,000 mg).

For radical cure of P. vivax and P. ovale infections, concomitant therapy with an 8­aminoquinoline drug is necessary [see Microbiology (12.4)].

2.3Dosage for Rheumatoid Arthritis in Adults The recommended dosage is: Initial dosage: 400 mg to 600 mg daily as a single daily dose or two divided doses. The action of hydroxychloroquine is cumulative and may require weeks to months for maximum therapeutic effect. Daily doses exceeding 5 mg/kg (actual weight) of hydroxychloroquine sulfate increase the incidence of retinopathy [see Warnings and Precautions (5.2)].

Chronic dosage: 200 mg, 300 mg or 400 mg daily, as a single dose or two divided doses. Corticosteroids, salicylates, and other antirheumatic agents may be used concomitantly with SOVUNA.

2.4Dosage for Systemic Lupus Erythematosus in Adults The recommended dosage is 200 mg, 300 mg or 400 mg daily, as a single dose or two divided doses

2.5Dosage for Chronic Discoid Lupus Erythematosus in Adults The recommended dosage is 200 mg or 400 mg daily, as a single dose or two divided doses.

💊 Dosage Forms and Strengths 103 words ▾

3 DOSAGE FORMS & STRENGTHS SOVUNA tablets are available in the following strengths: 200 mg of hydroxychloroquine sulfate: white to off-white, capsule-shaped, film-coated tablets, debossed with "172" on one side and plain on the other side. 300 mg of hydroxychloroquine sulfate: white to off-white, functionally scored, capsule-shaped, film-coated tablets, debossed with "1" on left side of the score and "71" on right side of the score and plain on the other side. The scoring allows the tablet to be divided into two equal halves containing 150 mg each.

Tablets: 200 mg of hydroxychloroquine sulfate Tablets: 300 mg of hydroxychloroquine sulfate; functionally scored (3)

⛔ Contraindications 20 words ▾

4 CONTRAINDICATIONS SOVUNA is contraindicated in patients with known hypersensitivity to 4-aminoquinoline compounds. Patients with hypersensitivity to 4-aminoquinoline compounds (4)

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Cardiomyopathy and Ventricular Arrhythmias : Fatal or life-threatening cardiomyopathy and ventricular arrhythmias were reported. (5.1) Retinal Toxicity : Irreversible retinal damage is related to cumulative dosage and treatment duration. Baseline retinal exam and exams during treatment are recommended.

(5.2) Serious Skin Reactions: Stevens Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, acute generalized exanthematous pustulosis have been reported. (5.3) Worsening of Psoriasis: Avoid in patients with psoriasis. (5.4) Risks Associated with Use in Porphyria: Avoid in patients with porphyria.

Hepatotoxicity was reported in patients with porphyria cutanea tarda (5.5) Hematologic Toxicity : Discontinue if myelosuppression occurs. (5.6) Renal Toxicity: Consider phospholipidosis as a possible cause of renal injury in patients with underlying connective tissue disorders. Discontinue SOVUNA if renal toxicity is suspected or demonstrated by tissue biopsy in any organ system.

(5.1, 5.8, 5.11)

5.1Cardiomyopathy and Ventricular Arrhythmias Fatal and life-threatening cases of cardiotoxicity, including cardiomyopathy, have been reported in patients treated with SOVUNA. Signs and symptoms of cardiac compromise have occurred during acute and chronic SOVUNA treatment. In multiple cases, endomyocardial biopsy showed association of the cardiomyopathy with phospholipidosis in the absence of inflammation, infiltration, or necrosis.

Drug-induced phospholipidosis may occur in other organ systems [see Warnings and Precautions (5.8, 5.11)]. Patients may present with ventricular hypertrophy, pulmonary hypertension and conduction disorders including sick sinus syndrome. ECG findings include atrioventricular, right or left bundle branch block.

SOVUNA has a potential to prolong the QT interval. Ventricular arrhythmias (including torsades de pointes) have been reported in SOVUNA-treated patients. The magnitude of QT prolongation may increase with increasing concentrations of the drug.

Therefore, the recommended dose should not be exceeded [see Adverse Reactions (6) , Overdosage (10)]. Avoid SOVUNA administration in patients with congenital or documented acquired QT prolongation and/or known risk factors for prolongation of the QT interval such as: Cardiac disease, e.g., heart failure, myocardial infarction. Proarrhythmic conditions, e.g., bradycardia (< 50 bpm).

History of ventricular dysrhythmias. Uncorrected hypokalemia and/or hypomagnesemia. Concomitant administration with QT interval prolonging agents as this may lead to an increased risk for ventricular arrhythmias [see Drug Interactions (7.1)].

Therefore, SOVUNA is not recommended in patients taking other drugs that have the potential to prolong the QT interval. Correct electrolyte imbalances prior to use. Monitor cardiac function as clinically indicated during SOVUNA therapy.

Discontinue SOVUNA if cardiotoxicity is suspected or demonstrated by tissue biopsy.

5.2Retinal Toxicity Irreversible retinal damage was observed in some patients treated with hydroxychloroquine sulfate and it is related to cumulative dosage and treatment duration. In patients of Asian descent, retinal toxicity may first be noticed outside the macula. Risk factors for retinal damage include daily hydroxychloroquine sulfate dosages ≥5 mg/kg of actual body weight, durations of use greater than five years, renal impairment, use of concomitant drug products such as tamoxifen citrate, and concurrent macular disease.

Within the first year of starting SOVUNA, a baseline ocular examination is recommended including best corrected distance visual acuity (BCVA), an automated threshold visual field (VF) of the central 10 degrees (with retesting if an abnormality is noted), and spectral domain ocular coherence tomography (SD-OCT). For patients at higher risk of retinal damage, monitoring should include annual examinations which include BCVA, VF and SD-OCT. For p…

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are described in greater detail in other sections: Cardiomyopathy and Ventricular Arrhythmias [see Warnings and Precautions (5.1)] Retinal Toxicity [see Warnings and Precautions (5.2)] Serious Skin Reactions [see Warnings and Precautions (5.3)] Worsening of Psoriasis [see Warnings and Precautions (5.4)] Risks Associated with Use in Porphyria [see Warnings and Precautions (5.5)] Hematologic Toxicity [see Warnings and Precautions (5.6)] Hemolytic Anemia Associated with G6PD [see Warnings and Precautions (5.7)] Skeletal Muscle Myopathy or Neuropathy [see Warnings and Precautions (5.8)] Neuropsychiatric Reactions Including Suicidality [see Warnings and Precautions (5.9)] Hypoglycemia [see Warnings and Precautions (5.10)] Renal Toxicity [see Warnings and Precautions (5.11)] The following adverse reactions have been identified during post-approval use of 4­ aminoquinoline drugs, including SOVUNA.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Blood and lymphatic system disorders : Bone marrow depression, anemia, aplastic anemia, agranulocytosis, leukopenia, thrombocytopenia Cardiac disorders: Cardiomyopathy, cardiac failure, QT-interval prolongation, ventricular tachycardia, torsades de pointes, atrioventricular block, bundle branch block, sick sinus syndrome, pulmonary hypertension Ear and labyrinth disorders : Vertigo, tinnitus, nystagmus, sensorineural hearing loss Eye disorders: Retinopathy, retinal pigmentation changes (typically bull’s eye appearance), visual field defects (paracentral scotomas), macular degeneration, corneal edema, corneal opacities, decreased dark adaptation Gastrointestinal disorders: Nausea, vomiting, diarrhea, abdominal pain General disorders : Fatigue Hepatobiliary disorders : Abnormal liver function tests, fulminant hepatic failure Immune system disorders : Urticaria, angioedema, bronchospasm Metabolism and nutrition disorders : Anorexia, hypoglycemia, weight loss Musculoskeletal and connective tissue disorders: Proximal myopathy, depressed tendon reflexes, abnormal nerve conduction Nervous system disorders: Ataxia, dizziness, headache, seizure, extrapyramidal disorders (dystonia, dyskinesia, tremor) Neuropsychiatric disorders: Affect/emotional lability, irritability, nervousness, psychosis, suicidal ideation, suicidal behavior, depression, hallucinations, anxiety, agitation, confusion, delusions, paranoia, mania and sleep disorders (insomnia, night terrors, nightmares) Skin and subcutaneous tissue disorders: Alopecia, hair color changes, rash, pruritus, photosensitivity, psoriasis exacerbation, hyperpigmentation, exfoliative dermatitis, erythema multiforme, acute generalized exanthematous pustulosis, Drug Rash with Eosinophilia and Systemic Symptoms (DRESS syndrome), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) The most common adverse reactions reported are: nausea, vomiting, diarrhea, and abdominal pain.

(6) To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-855-204-1431 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Drugs Prolonging QT Interval and Other Arrhythmogenic Drugs. (7.1) See FPI for more important drug interactions. (7)

7.1Drugs Prolonging QT Interval and Other Arrhythmogenic Drugs SOVUNA prolongs the QT interval. There may be an increased risk of inducing ventricular arrhythmias if SOVUNA is used concomitantly with other arrhythmogenic drugs. Therefore, SOVUNA is not recommended in patients taking other drugs that have the potential to prolong the QT interval or are arrhythmogenic [see Warnings and Precautions (5.1)].

7.2Insulin or Other Antidiabetic Drugs SOVUNA may enhance the effects of insulin and antidiabetic drugs, and consequently increase the hypoglycemic risk. Therefore, a decrease in dosage of insulin and other antidiabetic drugs may be necessary [see Warnings and Precautions (5.10 ) ] .

7.3Drugs that Lower the Seizure Threshold SOVUNA can lower the seizure threshold. Co-administration of SOVUNA with other antimalarials known to lower the seizure threshold (e.g., mefloquine) may increase the risk of seizures.

7.4Antiepileptics The activity of antiepileptic drugs might be impaired if co-administered with SOVUNA.

7.5Methotrexate Concomitant use of SOVUNA and methotrexate may increase the incidence of adverse reactions.

7.6Cyclosporine An increased plasma cyclosporin level was reported when cyclosporin and SOVUNA were co-administered. Monitor serum cyclosporine levels closely in patients receiving combined therapy.

7.7Digoxin Concomitant SOVUNA and digoxin therapy may result in increased serum digoxin levels. Monitor serum digoxin levels closely in patients receiving combined therapy.

7.8Cimetidine Concomitant use of cimetidine resulted in a 2-fold increase of exposure of chloroquine, which is structurally related to hydroxychloroquine. Interaction of cimetidine with hydroxychloroquine cannot be ruled out. Avoid concomitant use of cimetidine.

7.9Rifampicin Lack of efficacy of hydroxychloroquine was reported when rifampicin was concomitantly administered. Avoid concomitant use of rifampicin.

7.10Praziquantel Chloroquine has been reported to reduce the bioavailability of praziquantel. Interaction of praziquantel with hydroxychloroquine cannot be ruled out.

7.11Antacids and kaolin Antacids and kaolin can reduce absorption of chloroquine; an interval of at least 4 hours between intake of these agents and chloroquine should be observed. Interaction of antacids and kaolin with hydroxychloroquine cannot be ruled out.

7.12Ampicillin In a study of healthy volunteers, chloroquine significantly reduced the bioavailability of ampicillin. Interaction of ampicillin with hydroxychloroquine cannot be ruled out.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to SOVUNA during pregnancy. Encourage patients to register by contacting 1-877-311-8972. Risk Summary Prolonged clinical experience over decades of use and available data from published epidemiologic and clinical studies with hydroxychloroquine use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal, or fetal outcomes (see Data) .

There are risks to the mother and fetus associated with untreated or increased disease activity from malaria, rheumatoid arthritis, and systemic lupus erythematosus in pregnancy (see Clinical Considerations). Animal reproduction studies were not conducted with hydroxychloroquine. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo-Fetal Risk Malaria : Malaria during pregnancy increases the risk for adverse pregnancy outcomes, including maternal anemia, prematurity, spontaneous abortion, and stillbirth.

Rheumatoid Arthritis: Published data suggest that increased disease activity is associated with the risk of developing adverse pregnancy outcomes in women with rheumatoid arthritis Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth. Systemic Lupus Erythematosus : Pregnant women with systemic lupus erythematosus, especially those with increased disease activity, are at increased risk of adverse pregnancy outcomes, including spontaneous abortion, fetal death, preeclampsia, preterm birth, and intrauterine growth restriction.

Passage of maternal auto-antibodies across the placenta may result in neonatal illness, including neonatal lupus and congenital heart block. Data Human Data Data from published epidemiologic and clinical studies have not established an association with SOVUNA use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes. Hydroxychloroquine readily crosses the placenta with cord blood levels corresponding to maternal plasma levels.

No retinal toxicity, ototoxicity, cardiotoxicity, or growth and developmental abnormalities have been observed in children who were exposed to hydroxychloroquine in utero . Available epidemiologic and clinical studies have methodological limitations including small sample size and study design.

8.2Lactation Risk Summary Published lactation data report that hydroxychloroquine is present in human milk at low levels. No adverse reactions have been reported in breastfed infants. No retinal toxicity, ototoxicity, cardiotoxicity, or growth and developmental abnormalities have been observed in children who were exposed to hydroxychloroquine through breastmilk.

There is no information on the effect of hydroxychloroquine on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SOVUNA and any potential adverse effects on the breastfed child from SOVUNA or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of SOVUNA have been established in pediatric patients for the treatment of uncomplicated malaria due to P. falciparum, P. malariae, P. vivax , and P. ovale, as well as for the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported. However, this product cannot be directly administered to pediatric patients weighing less than 23 kg because the lowest possible dose of 150…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to SOVUNA during pregnancy. Encourage patients to register by contacting 1-877-311-8972. Risk Summary Prolonged clinical experience over decades of use and available data from published epidemiologic and clinical studies with hydroxychloroquine use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal, or fetal outcomes (see Data) .

There are risks to the mother and fetus associated with untreated or increased disease activity from malaria, rheumatoid arthritis, and systemic lupus erythematosus in pregnancy (see Clinical Considerations). Animal reproduction studies were not conducted with hydroxychloroquine. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo-Fetal Risk Malaria : Malaria during pregnancy increases the risk for adverse pregnancy outcomes, including maternal anemia, prematurity, spontaneous abortion, and stillbirth.

Rheumatoid Arthritis: Published data suggest that increased disease activity is associated with the risk of developing adverse pregnancy outcomes in women with rheumatoid arthritis Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth. Systemic Lupus Erythematosus : Pregnant women with systemic lupus erythematosus, especially those with increased disease activity, are at increased risk of adverse pregnancy outcomes, including spontaneous abortion, fetal death, preeclampsia, preterm birth, and intrauterine growth restriction.

Passage of maternal auto-antibodies across the placenta may result in neonatal illness, including neonatal lupus and congenital heart block. Data Human Data Data from published epidemiologic and clinical studies have not established an association with SOVUNA use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes. Hydroxychloroquine readily crosses the placenta with cord blood levels corresponding to maternal plasma levels.

No retinal toxicity, ototoxicity, cardiotoxicity, or growth and developmental abnormalities have been observed in children who were exposed to hydroxychloroquine in utero . Available epidemiologic and clinical studies have methodological limitations including small sample size and study design.

🧒 Pediatric Use 120 words ▾

8.4Pediatric Use The safety and effectiveness of SOVUNA have been established in pediatric patients for the treatment of uncomplicated malaria due to P. falciparum, P. malariae, P. vivax , and P. ovale, as well as for the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported. However, this product cannot be directly administered to pediatric patients weighing less than 23 kg because the lowest possible dose of 150 mg (half of the scored 300 mg tablet) exceeds the recommended dose for these patients [see Dosage and Administration (2.2)] .

The safety and effectiveness of SOVUNA have not been established in pediatric patients for the treatment of rheumatoid arthritis, chronic discoid lupus erythematosus, or systemic lupus erythematosus.

🧓 Geriatric Use 95 words ▾

8.5Geriatric Use Clinical trials of SOVUNA did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients. Nevertheless, this drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. In general, dose selection in geriatric patients should start with the lowest recommended dose, taking into consideration the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

🆘 Overdosage 130 words ▾

10 OVERDOSAGE SOVUNA overdosage symptoms have an onset within 1–3 hours of ingestion. The following have been reported with SOVUNA overdosage: Cardiovascular toxicity, including QRS or QTc prolongation, ventricular tachycardia, ventricular fibrillation, torsade de pointes, atrioventricular block, cardiac arrest and death. Life-threatening hypotension is common.

Severe hypokalemia secondary to an intracellular shift is common in severe toxicity. Central nervous system (CNS) depression, seizures, visual disturbances, transient blindness, and coma may occur. Gastrointestinal decontamination procedures warrant consideration in patients that present within the first hour post-ingestion.

If the level of consciousness rapidly deteriorates in severe poisoning, consider intubation before gastrointestinal decontamination procedures. Monitor plasma potassium levels and manage accordingly. Hemofiltration, hemodialysis, and hemoperfusion are not of benefit.

Consider contacting a poison center (1-800-221-2222) or a medical toxicologist for overdosage management recommendations.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Malaria Hydroxychloroquine is a 4-aminoquinoline antimalarial [see Microbiology (12.4)] and antirheumatic agent. Rheumatoid Arthritis, Systemic Lupus Erythematosus and Chronic Discoid Lupus Erythematosus The mechanisms underlying the anti-inflammatory and immunomodulatory effects of SOVUNA in the treatment of rheumatoid arthritis, chronic discoid lupus erythematosus and systemic lupus erythematosus are not fully known.

12.2Pharmacodynamics The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of hydroxychloroquine have not been fully characterized.

12.3Pharmacokinetics Following oral administration, the whole blood concentration of hydroxychloroquine at steady state is dose proportional over a dose range from 200 mg daily to 400 mg daily of hydroxychloroquine in rheumatoid arthritis and lupus patients. Absorption Following a single 200 mg oral dose of hydroxychloroquine to healthy male volunteers, whole blood hydroxychloroquine C max was 129.6 ng/mL (plasma C max was 50.3 ng/mL) with T max of 3.3 hours (plasma T max 3.7 hours). Peak blood concentrations of metabolites were observed at the same time as peak levels of hydroxychloroquine.

Mean absolute oral bioavailability is 79% (SD: 12%) in fasting conditions. Peak blood concentrations ranged from 1161 ng/mL to 2436 ng/mL (mean 1918 ng/mL) following a single dose of 155 mg intravenous infusion and from 2290 ng/mL to 4211 ng/mL (mean 3312 ng/mL) following a single dose of 310 mg intravenous infusion in healthy subjects. Pharmacokinetic parameters were not significantly different over the therapeutic dose range of 155 mg and 310 mg indicating linear kinetics.

In patients with rheumatoid arthritis, there was large variability as to the fraction of the dose absorbed (i.e., 30 to 100%), and mean hydroxychloroquine levels were significantly higher in patients with less disease activity. Distribution Hydroxychloroquine is extensively distributed to tissues and has a large volume of distribution. Approximately 50% of hydroxychloroquine is bound to plasma proteins.

Metabolism Significant levels of three metabolites, desethylhydroxychloroquine (DHCQ), desethylchloroquine (DCQ), and bidesethylhydroxychloroquine (BDCQ) were found in plasma and blood, with DHCQ being the major metabolite. In vitro, hydroxychloroquine is metabolized mainly by CYP2C8, CYP3A4 and CYP2D6 as well as by FMO-1 and MAO-A. Elimination / Excretion Renal clearance in patients with rheumatoid arthritis treated with hydroxychloroquine for at least 6 months was similar to that in single dose studies in healthy volunteers, suggesting that no change in clearance occurred with chronic dosing.

Renal clearance of unchanged hydroxychloroquine was approximately 16% to 30% of the dose after oral and IV administration. Results following a single oral dose of a 200 mg tablet demonstrated a half-life of hydroxychloroquine about 40 days in whole blood. Following chronic oral administration of hydroxychloroquine, the absorption half-life of hydroxychloroquine was approximately 3 to 4 hours and the terminal half-life ranged from 40 to 50 days in whole blood.

The effective half-life of hydroxychloroquine is likely to be shorter and steady state is achieved by 6 weeks following 400 mg daily oral administration in rheumatoid arthritis patients. Drug Interaction Studies In vitro study suggested that hydroxychloroquine has a potential to inhibit CYP2D6, CYP3A4, P-glycoproteins (P-gp), MATE1 and MATE2-K. In vitro study suggested that hydroxychloroquine has no significant potential to inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and the main transporters OATP1B1, OATP1B3, OAT1, OAT3, OCT1, and OCT2.

In vitro, hydroxychloroquine has no significant potential to induce CYP1A2, CYP2B6 and CYP3A4.

12.4Microbiology Mechanism of Action in Malaria The precise mechanism by which hydroxychloroquine exhibits activity against Plasmodium is…

🧬 Mechanism of Action 54 words ▾

12.1Mechanism of Action Malaria Hydroxychloroquine is a 4-aminoquinoline antimalarial [see Microbiology (12.4)] and antirheumatic agent. Rheumatoid Arthritis, Systemic Lupus Erythematosus and Chronic Discoid Lupus Erythematosus The mechanisms underlying the anti-inflammatory and immunomodulatory effects of SOVUNA in the treatment of rheumatoid arthritis, chronic discoid lupus erythematosus and systemic lupus erythematosus are not fully known.

📦 How Supplied / Storage and Handling 150 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied SOVUNA (hydroxychloroquine sulfate) Tablets are available in the following strengths and packing configurations: 200 mg of hydroxychloroquine sulfate: white to off-white, capsule-shaped, film-coated tablets, debossed with "172" on one side and plain on the other side. Bottles of 30 tablets with child resistant closure (NDC 70954-804-10) Bottles of 100 tablets with child resistant closure (NDC 70954-804-20) 300 mg of hydroxychloroquine sulfate: white to off-white, functionally scored, capsule-shaped, film-coated tablets, debossed with "1" on left side of the score and "71" on right side of the score and plain on the other side.

Bottles of 100 tablets with child resistant closure (NDC 70954-805-10)

16.2Storage Dispense in a tight, light-resistant container as defined in the USP/NF. Keep out of the reach of children. Store at room temperature between 20°C and 25°C (68°F and 77°F), allow excursions between 15°C and 30°C (59°F and 86°F).

📋 Description 139 words ▾

11 DESCRIPTION SOVUNA contains hydroxychloroquine sulfate, an antimalarial and antirheumatic drug, chemically described as 2-[[4-[(7-Chloro-4- quinolyl)amino]pentyl]ethylamino] ethanol sulfate (1:1) with the molecular formula C 18 H 26 ClN 3 O•H 2 SO 4 . The molecular weight of hydroxychloroquine sulfate is 433.95. Its structural formula is: Hydroxychloroquine sulfate is a white or off-white crystalline powder, freely soluble in water; practically soluble in alcohol, chloroform, and ether.

Each SOVUNA (hydroxychloroquine sulfate) Tablet, 200 mg for oral administration contains 200 mg hydroxychloroquine sulfate, equivalent to 155 mg base. Each SOVUNA (hydroxychloroquine sulfate) Tablet, 300 mg for oral administration contains 300 mg hydroxychloroquine sulfate, equivalent to 232 mg base. Inactive Ingredients: Corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, sucralose, talc, titanium dioxide, triacetin and water.

FDA approved dissolution test and acceptance criterion differ from USP. structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Important Administration Instructions Advise the patient to take SOVUNA with food or milk and not to crush the tablet. Cardiomyopathy and Ventricular Arrhythmias Inform the patient that serious cardiac effects, life-threatening and fatal cases have been reported with use of SOVUNA. Advise patients to seek medical attention immediately if they experience any symptoms of heart rhythm changes including fast or irregular heartbeat, lightheadedness, dizziness, or syncope [see Warnings and Precautions (5.1)].

Retinal Toxicity Inform the patient that irreversible retinal damage has been observed in some patients with the use of SOVUNA. Advise patients of the importance of the ophthalmology visits for monitoring their eyes. Instruct patients to seek medical attention promptly if they experience decreased vision or decreased dark adaptation [see Warnings and Precautions (5.2)].

Serious Skin Reactions Inform the patient that severe, life-threatening skin reactions have been reported with the use of SOVUNA. Advise the patient to seek medical attention immediately if experiencing any of the following signs and symptoms: blisters on the skin, eyes, lips or in the mouth, itching or burning, with or without fever [see Warnings and Precautions (5.3)]. Hepatotoxicity Associated with Porphyria Cutanea Tarda Inform the patient that liver toxicity has been reported when SOVUNA was used in patients with porphyria cutanea tarda.

In some cases, PCT was diagnosed only after the occurrence of liver injury, when SOVUNA was prescribed for an approved indication. Advise the patient to seek medical attention if experiencing fatigue, rash, nausea, dark urine, or jaundice [see Warnings and Precautions (5.5)]. Skeletal Muscle Myopathy or Neuropathy Inform the patient that muscle weakness and atrophy has been reported with SOVUNA use.

Advise patients to report to the physician symptoms of muscle weakness [see Warnings and Precautions (5.8)] . Neuropsychiatric Reactions Including Suicidality Alert patients to seek medical attention immediately if they experience new or worsening depression, suicidal thoughts, or other mood changes [see Warnings and Precautions (5.9)]. Hypoglycemia Inform the patient that SOVUNA has been associated with severe hypoglycemia.

Advise the patient to monitor blood sugar levels if possible and to seek medical attention if experiencing any of the signs and symptoms of hypoglycemia such as sweating, shakiness, weakness, dizziness, tachycardia, nausea, blurred vision, confusion, fainting, or loss of consciousness [see Warnings and Precautions (5.10)]. Pregnancy Inform the patient that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to SOVUNA during pregnancy. Encourage patients to register by contacting 1-877­311-8972 [see Use in Specific Populations (8.1)] .

SOVUNA ® is a registered trademark of ANI Pharmaceuticals, Inc. Distributed by: ANI Pharmaceuticals, Inc. Baudette, MN 56623 LB4637-03

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 70954-0801-10 · ANI 70954-0805-10 · ANI →
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.