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Sorafenib 200 mg Tablet, Film Coated, 60-count — NDC 13668-0682-60 package photo

Sorafenib 200 mg Tablet, Film Coated, 60-count

by Torrent Pharmaceuticals Limited · 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (13668-682-60)
NDC 13668-0682-60
🏷️ FDA NDC (as labeled) 13668-682-60 billing pads the product segment with a zero
This package
Contains60-count Pack sizes4 compare ↓
Also priced by: Part D plans $94.87/unit — full pricing hub ↓
Also comes in: 10 tablets 13668-0682-74 30 tablets 13668-0682-30 120 tablets 13668-0682-12
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

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

🆔 Identity & classification

FDA NDC (as labeled) 13668-682-60
Product NDC 13668-682
11-digit billing NDC 13668068260
RxCUI 597747
UNII 9ZOQ3TZI87
UPC 0313668682304
Application # ANDA217095
SPL Set ID b5305e23-7bc6-44d8-b177-930c47d1653a
Established class (EPC) Kinase Inhibitor
Mechanism of action Protein Kinase Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-04-12
Route ORAL
Dosage form TABLET, FILM COATED
Substance SORAFENIB
GPI-14 21533060400320
GCN Seq No 060199
GCN 26263
HICL code 033400
Ingredient (HICL) Sorafenib Tosylate
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V1
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs
HIC3 code V1Q
Therapeutic class — specific (HIC3) Antineoplastic Systemic Enzyme Inhibitors
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name SORAFENIB 200 MG TABLET
FDB brand name Sorafenib
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 13668-682-60 — 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 → 13668-0682-60. 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 Kinase Inhibitor class.

Pharmacologic class Kinase Inhibitor
Drug family (ATC) Other protein kinase inhibitors
How it works Protein Kinase 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

LabelerTorrent Pharmaceuticals Limited
Application holderTORRENT PHARMACEUTICALS LTD
FDA applicationANDA217095 (ANDA)
Labeler code13668
First marketedApr 2023
Product typeHuman Prescription Drug
Portfolio182 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 SORAFENIB 200 MG TABLET Ingredient Sorafenib Tosylate
📖 What it is MedlinePlus · NLM

Sorafenib is used to treat advanced renal cell carcinoma (RCC; a type of cancer that begins in the kidneys). Sorafenib is also used to treat hepatocellular carcinoma (a type of liver cancer) that cannot be treated with surgery and a certain type of thyroid cancer that has spread to other parts of the body and cannot be treated with radioactive iodine. Sorafenib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Sorafenib — sold as the brand Nexavar or as a generic — is approved for three specific cancers: liver cancer that can't be surgically removed (hepatocellular carcinoma), advanced k...
  • What cancers does sorafenib actually treat?
  • Yes — it really does. You should take sorafenib on an empty stomach, at least 1 hour before eating or 2 hours after a meal. A high-fat meal can reduce how much of the medicine your...
  • Does it matter if I take sorafenib with food?
📖 Read our full Sorafenib guide →
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.

🧪 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 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 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 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 OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • 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 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • 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 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 · Q2 2026 $94.87 $5,692.46 / 60 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
Sorafenib Tosylate 200 mg 00378-1201-78 Mylan 120 tablets — AB FDA listed —
Sorafenib 200 mg 00480-5425-89 Teva 120 tablets — AB FDA listed —
Sorafenib 200 mgthis 13668-0682-60 Torrent 60 tablets — AB FDA listed —
sorafenib 200 mg 24979-0715-04 Upsher-Smith 60 tablets — AB FDA listed —
sorafenib 200 mg 43598-0458-04 Dr.Reddys 120 tablets — AB FDA listed —
Nexavar 200 mg 50419-0488-58 Bayer 120 tablets — AB FDA listed —
Nexavar 200 mg 50419-0489-01 Bayer 120 tablets — AB FDA listed —
sorafenib 200 mg 51407-0760-12 Golden 120 tablets — AB FDA listed —
sorafenib 200 mg 51990-0201-06 Yabao 60 tablets — 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

🏛️
2023
On the market since
Apr 2023
📍
2026
Currently FDA-listed
3 years listed
🔓
·
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.

💊 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.
120 tablets13668-0682-12 59 Rx · $238,755
30 tablets13668-0682-30 No Medicaid data
60 tablets this page13668-0682-60 No Medicaid data
10 tablets13668-0682-74 No Medicaid data
Drug total (last 4 qtrs): 59 Rx · 4,270 units · $238,755 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 Sorafenib — the program that covers self-administered drugs. 5 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 Sorafenib. 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
$3.4M
Claims incl. refills
592
Beneficiaries
285
Spend / beneficiary
$11,930.60
Spend / claim
$5,743.62
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
13668-0682-12 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (13668-682-12) 2023-04-12 Active
13668-0682-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (13668-682-30) 2023-04-12 Active
13668-0682-60 You're viewing this 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (13668-682-60) 2023-04-12 Active
13668-0682-74 10 BLISTER PACK in 1 CARTON (13668-682-74) / 10 TABLET, FILM COATED in 1 BLISTER PACK 2023-04-12 Active

Pack size FAQ

What quantity is in NDC 13668-0682-60?
NDC 13668-0682-60 is a 60-count package — 60 tablet, film coated in 1 bottle, plastic.
What is the difference between NDC 13668-0682-60 and NDC 13668-0682-30?
Both are Sorafenib 200 mg Tablet, Film Coated — the drug itself is identical. NDC 13668-0682-60 is the 60-count package, while NDC 13668-0682-30 is the 30 tablets package.
What NDC number is used to bill for this package of Sorafenib 200 mg Tablet, Film Coated?
Bill NDC 13668-0682-60 — the 11-digit billing format is 13668068260. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — 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 13668-682-60, 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: 13668-0682-60, written without dashes as 13668068260. 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 13668-0682-60, the first segment (13668) is the labeler code FDA assigned to Torrent Pharmaceuticals Limited; the middle segment (0682) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (60) 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 Torrent Pharmaceuticals Limited. 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 3 other package presentations of this same product, including 10 tablets (13668-0682-74), 30 tablets (13668-0682-30), 120 tablets (13668-0682-12). 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?
Torrent Pharmaceuticals Limited 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 114 words ▾

1 INDICATIONS AND USAGE Sorafenib tablets are a kinase inhibitor indicated for the treatment of • Unresectable hepatocellular carcinoma ( 1.1 ) • Advanced renal cell carcinoma ( 1.2 ) • Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refractory to radioactive iodine treatment ( 1.3 )

1.1Hepatocellular Carcinoma Sorafenib tablets are indicated for the treatment of patients with unresectable hepatocellular carcinoma (HCC).

1.2Renal Cell Carcinoma Sorafenib tablets are indicated for the treatment of patients with advanced renal cell carcinoma (RCC).

1.3Differentiated Thyroid Carcinoma Sorafenib tablets are indicated for the treatment of patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) that is refractory to radioactive iodine treatment.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION The recommended dosage is 400 mg orally twice daily without food. ( 2.1 )

2.1Recommended Dosage The recommended dosage of sorafenib tablets are 400 mg orally twice daily without food (at least 1 hour before or 2 hours after a meal) until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity.

2.2Dosage Modifications for Adverse Reactions Recommended Dosage Modifications The recommended dosage modifications for adverse reactions are provided in Tables 1, 2, and 3. Table 1: Recommended Dose Reductions for Adverse Reactions Dose Reduction Hepatocellular Carcinoma and Renal Cell Carcinoma Differentiated Thyroid Carcinoma First Dose Reduction 400 mg orally once daily 400 mg orally in the morning and 200 mg orally in the evening about 12 hours apart OR 200 mg orally in the morning and 400 mg orally in the evening about 12 hours apart Second Dose Reduction 200 mg orally once daily OR 400 every other day 200 mg orally twice daily Third Dose Reduction None 200 mg orally once daily Table 2: Recommended Dosage Modifications of Sorafenib Tablets for Adverse Reactions Adverse Reaction Severity 1 Sorafenib Tablets Dosage Modification Cardiovascular Events [see Warnings and Precautions ( 5.1 )] Cardiac Ischemia and/or Infarction Grade 2 and above Permanently discontinue.

Congestive Heart Failure Grade 3 Interrupt 2 until Grade 1 or less, resume at reduced dose by 1 dose level. 3 Grade 4 Permanently discontinue. Hemorrhage [see Warnings and Precautions ( 5.2 )] Grade 2 and above requiring medical intervention Permanently discontinue.

Hypertension [see Warnings and Precautions ( 5.3 )] Grade 2 (symptomatic/persistent) OR Grade 2 symptomatic increase by greater than 20 mm Hg (diastolic) or greater than 140/90 mm Hg if previously within normal limits OR Grade 3 Interrupt until symptoms resolve and diastolic blood pressure less than 90 mm Hg, then resume at reduced dose by 1 dose level. 3 If needed, reduce another dose level. 3 Grade 4 Permanently discontinue.

Gastrointestinal Perforation [see Warnings and Precautions ( 5.5 )] Any grade Permanently discontinue. QT Interval Prolongation [see Warnings and Precautions ( 5.9 )] Greater than 500 milliseconds OR Increase from baseline of 60 milliseconds or greater Interruptand correct electrolyte abnormalities (magnesium, potassium, calcium). Use medical judgement before restarting.

Drug-Induced Liver Injury [see Warnings and Precautions ( 5.10 )] Grade 3 ALT or higher in the absence of another cause 4 OR AST/ALT greater than 3 × upper limit normal (ULN) with bilirubin greater than 2 × ULN in the absence of another cause 4 Permanently discontinue. Non-hematological toxicities [see Adverse Reactions ( 6.1 )] Grade 2 Continue treatment at reduced dose by 1 dose level. Grade 3 1 st occurrence Interrupt until Grade 2 or less, then resume at reduced dose by 1 dose level.

No improvement within 7 days OR 2 nd or 3 rd occurrence Interrupt until Grade 2 or less, then resume at reduced dose by 2 dose levels. 4 th occurrence Interrupt until Grade 2 or less, then resume at reduced dose by 2 dose levels for HCC and RCC or 3 dose levels for DTC. Grade 4 Permanently discontinue.

1 Adverse reactions graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v3.0). 2 If no recovery after 30 day interruption, discontinue treatment unless the patient is deriving clinical benefit. 3 If more than 2 dose reductions are required, permanently discontinue treatment.

4 In addition, any grade increased alkaline phosphatase in the absence of known bone pathology and Grade 2 or worse increased bilirubin; any 1 of the following: INR of 1.5 or greater, ascites and/or encephalopathy in the absence of underlying cirrhosis or other organ failure considered to be due to drug-induced liver injury. Table 3: Recommended Dosage Modifications for Dermatologic Toxicities Dermatologic Toxicity Grade Occurrence Sorafenib Ta…

💊 Dosage Forms and Strengths 32 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablets: 200 mg sorafenib, round biconvex, red film-coated tablets, debossed with "F11" on one side and plain on the other side. Tablets: 200 mg ( 3 )

⛔ Contraindications 88 words ▾

4 CONTRAINDICATIONS •Sorafenib tablets are contraindicated in patients with known severe hypersensitivity to sorafenib or any other component of sorafenib tablets. •Sorafenib tablets in combination with carboplatin and paclitaxel is contraindicated in patients with squamous cell lung cancer [see Warnings and Precautions ( 5.8 )] . •Sorafenib tablets are contraindicated in patients with known severe hypersensitivity to sorafenib or any other component of sorafenib tablets. ( 4 ) •Sorafenib tablets in combination with carboplatin and paclitaxel are contraindicated in patients with squamous cell lung cancer.

( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Cardiovascular Events : Consider temporary or permanent discontinuation of sorafenib tablets. ( 2.2 , 5.1 ) • Hemorrhage: Discontinue sorafenib tablets if needed. ( 5.2 ) • Hypertension: Monitor blood pressure weekly during the first 6 weeks and periodically thereafter.

Consider temporary or permanent discontinuation for severe or persistent hypertension despite antihypertensive therapy. ( 5.3 ) • Dermatologic Toxicities : Interrupt and/or decrease dose. Discontinue for severe or persistent reactions, or if Stevens-Johnson syndrome and toxic epidermal necrolysis is suspected.

( 5.4 ) • Gastrointestinal Perforation : Discontinue sorafenib tablets. ( 5.5 ) • Risk of Impaired Wound Healing : Withhold sorafenib tablets for at least 10 days prior to elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing.

The safety of resumption of Sorafenib tablets after resolution of wound healing complications has not been established. ( 5.7 ) • QT Prolongation : Monitor electrocardiograms and electrolytes in patients at increased risk for ventricular arrhythmias. Correct electrolytes.

Interrupt if QTc greater than 500 msec or increases greater than 60 msec from baseline. ( 2.2 , 5.9 , 12.2 ) • Drug-Induced Liver Injury : Monitor liver function tests regularly; discontinue for unexplained transaminase elevations. ( 5.10 ) • Embryo-Fetal Toxicity : Sorafenib may cause fetal harm.

Advise patients of the potential risk to a fetus and to use effective contraception. ( 5.11 , 8.1 , 8.3 ) • Impairment of Thyroid Stimulating Hormone Suppression (TSH) in DTC : Monitor TSH monthly and adjust thyroid replacement therapy in patients with thyroid cancer. ( 5.12 )

5.1Cardiovascular Events In the SHARP (HCC) study, the incidence of cardiac ischemia/infarction was 2.7% in sorafenib tablets-treated patients compared with 1.3% in those receiving placebo; in the TARGET (RCC) study, the incidence of cardiac ischemia/infarction was higher in the sorafenib tablets-treated group (2.9%) compared with patients receiving placebo (0.4%), and in the DECISION (DTC) study, the incidence of cardiac ischemia/infarction was 1.9% in the sorafenib tablets-treated group compared with 0% in patients receiving placebo.

Patients with unstable coronary artery disease or recent myocardial infarction were excluded from this study. In multiple clinical trials, congestive heart failure has been reported in 1.9% of sorafenib tablets-treated patients (N=2,276) [see Adverse Reactions ( 6.2 )] . Consider temporary or permanent discontinuation of sorafenib tablets in patients who develop cardiovascular events [see Dosage and Administration ( 2.2 )].

5.2Hemorrhage An increased risk of bleeding may occur following sorafenib tablets administration. In the SHARP (HCC) study, the rates of bleeding from esophageal varices (2.4% and 4%) and of bleeding with a fatal outcome from any site (2.4% and 4%) were similar in sorafenib tablets-treated patients and those receiving placebo, respectively . In the TARGET (RCC) study, bleeding was reported in 15.3% of patients in the sorafenib tablets-treated group and 8.2% of patients receiving placebo.

The incidence of Grade 3 and 4 bleeding was 2% and 0%, respectively, in sorafenib tablets-treated patients, and 1.3% and 0.2%, respectively, in those receiving placebo. There was one fatal hemorrhage in each treatment group in the TARGET (RCC) study. In the DECISION (DTC) study, bleeding was reported in 17.4% of sorafenib tablets-treated patients and 9.6% of those receiving placebo; however, the incidence of Grade 3 bleeding was similar (1% and 1.4%) in sorafenib tablets-treated patients and in those receiving placebo.

If any bleeding necessitates medical intervention, consider permanent discontinuation of sorafenib tablets [see Dosage and Administration ( 2.2 )] . Due to the potential risk of bleeding, treat tracheal, bronchial, and esophageal infiltration with local therapy…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed elsewhere in the labeling: • Cardiovascular events [see Warnings and Precautions ( 5.1 )] • Hemorrhage [see Warnings and Precautions ( 5.2 )] • Hypertension [see Warnings and Precautions ( 5.3 )] • Dermatologic toxicities [see Warnings and Precautions ( 5.4 )] • Gastrointestinal perforation [see Warnings and Precautions ( 5.5 )] • QT interval prolongation [see Warnings and Precautions ( 5.9 ) and Clinical Pharmacology ( 12.2 )] • Drug-induced liver injury [see Warnings and Precautions ( 5.10 )] • Impairment of TSH suppression in DTC [see Warnings and Precautions ( 5.12 )] The most common adverse reactions (≥20%) are diarrhea, fatigue, infection, alopecia, hand-foot skin reaction, rash, weight loss, decreased appetite, nausea, gastrointestinal and abdominal pains, hypertension, and hemorrhage.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma Inc. at 1-800-912-9561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials 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. The data described reflect exposure to sorafenib tablets in 955 patients who participated in placebo-controlled studies in hepatocellular carcinoma (N=297), advanced renal cell carcinoma (N=451), or differentiated thyroid carcinoma (N = 207).

The most common adverse reactions (≥20%), which were considered to be related to sorafenib tablets, in patients with HCC, RCC or DTC are diarrhea, fatigue, infection, alopecia, hand-foot skin reaction, rash, weight loss, decreased appetite, nausea, gastrointestinal and abdominal pains, hypertension, and hemorrhage. Hepatocellular Carcinoma Table 4 shows the percentage of patients in the SHARP (HCC) study experiencing adverse reactions that were reported in at least 10% of patients and at a higher rate in the sorafenib-treated group than in those receiving placebo.

Table 4: Adverse Reactions Reported in at Least 10% of Patients and at a Higher Rate in Sorafenib Tablets Arm than the Placebo Arm - SHARP (HCC) Adverse Reaction 1 Sorafenib Tablets N=297 Placebo N=302 All Grades % Grade 3 % Grade 4% All Grades % Grade 3% Grade 4% Any Adverse Reaction 98 39 6 96 24 8 Gastrointestinal Diarrhea 55 10 <1 25 2 0 Anorexia 29 3 0 18 3 <1 Nausea 24 1 0 20 3 0 Vomiting 15 2 0 11 2 0 Constipation 14 0 0 10 0 0 Constitutional symptoms Fatigue 46 9 1 45 12 2 Weight loss 30 2 0 10 1 0 Pain Pain, abdomen 31 9 0 26 5 1 Dermatology/Skin Hand-foot skin reaction 21 8 0 3 <1 0 Rash/desquamation 19 1 0 14 0 0 Alopecia 14 0 0 2 0 0 Pruritus 14 <1 0 11 <1 0 Dry Skin 10 0 0 6 0 0 Hepatobiliary/ pancreas Liver dysfunction 11 2 1 8 2 1 1 Adverse reactions graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v3.0).

Hypertension was reported in 9% of patients treated with sorafenib tablets and 4% of those receiving placebo. Grade 3 hypertension was reported in 4% of sorafenib tablets-treated patients and 1% of those receiving placebo. Hemorrhage/bleeding was reported in 18% of those receiving sorafenib tablets and 20% of patients receiving placebo.

The rates of Grade 3 and 4 bleeding were also higher in patients receiving placebo (Grade 3 to 3% sorafenib tablets and 5% placebo and Grade 4 to 2% sorafenib tablets and 4% placebo). Bleeding from esophageal varices was reported in 2.4% in sorafenib tablets-treated patients and 4% of patients receiving placebo. Renal failure was reported in <1% of patients treated with sorafenib tablets and 3% of patients receiving placebo.

Clinical pancreatitis was reported in 1 of 297 sorafenib tablets-treated patients (Grade 2). The rate of adverse reactions (including those associated with progressive disease) resulting in…

🔄 Drug Interactions 208 words ▾

7 DRUG INTERACTIONS Strong CYP3A Inducers: Avoid strong CYP3A4 inducers. ( 7.1 )

7.1Effect of Other Drugs on Sorafenib Strong CYP3A4 Inducers The concomitant use of sorafenib with rifampin, a strong CYP3A4 inducer decreased the mean AUC of sorafenib, which may decrease the antitumor activity [see Clinical Pharmacology ( 12.3 )] . Avoid concomitant use of sorafenib with strong CYP3A4 inducers, when possible, because these drugs can decrease the systemic exposure to sorafenib. Neomycin The concomitant use of sorafenib with neomycin decreased the mean AUC of sorafenib, which may decrease the antitumor activity.

Avoid concomitant use of sorafenib with neomycin. The effects of other antibiotics on the pharmacokinetics of sorafenib have not been studied [see Clinical Pharmacology ( 12.3 )].

7.2Concomitant Use of Warfarin The concomitant use of sorafenib and warfarin may increase the risk of bleeding or increased the INR. Monitor INR and for clinical bleeding episodes in patients taking warfarin while receiving sorafenib [see Warnings and Precautions ( 5.6 )].

7.3Drugs That Prolong the QT Interval Sorafenib tablets are associated with QTc interval prolongation. Avoid coadministration of sorafenib tablets with medicinal products with a known potential to prolong QT/QTc interval [see Warnings and Precautions ( 5.9 ), Clinical Pharmacology ( 12.2 )] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation : Advise women not to breastfeed. ( 8.2 )

8.1Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology ( 12.1 )] , sorafenib may cause fetal harm when administered to a pregnant woman. There are no available data in pregnant women to inform a drug-associated risk. In animal reproduction studies, oral administration of sorafenib to pregnant rats and rabbits during the period of organogenesis resulted in embryo-fetal toxicities at maternal exposures that were significantly lower than human exposures at the recommended dose of 400 mg twice daily (see Data).

Advise pregnant women and females of reproductive potential of the potential risk to a fetus. The background risk of major birth defects and miscarriage for 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.

Data Animal Data In animal reproduction studies, sorafenib was teratogenic and induced embryo-fetal toxicity (including increased post-implantation loss, resorptions, skeletal retardations, and retarded fetal weight) when administered orally to pregnant rats and rabbits during the period of organogenesis. The effects occurred at doses considerably below the recommended human dose of 400 mg twice daily (approximately 500 mg/m 2 /day on a body surface area basis). Adverse intrauterine development effects were seen at doses >0.2 .mg/kg/day (1.2 mg/m 2 /day) in rats and ≥0.3 mg/kg/day (≥3.6 mg/m 2 /day) in rabbits.

These doses result in exposures (AUC) that are approximately 0.008 times the AUC in patients at the recommended dose.

8.2Lactation Risk Summary There are no data on the presence of sorafenib or its metabolites in human milk, or its effects on the breast-fed child or on milk production. Sorafenib was present in milk of lactating rats ( see Data ). Because of the potential for serious adverse reactions in a breastfed child from sorafenib tablets, advise women not to breastfeed during treatment with sorafenib tablets and for 2 weeks after the last dose.

Data Animal Data Following administration of radiolabeled sorafenib to lactating Wistar rats, approximately 27% of the radioactivity was secreted into milk. The milk to plasma AUC ratio was approximately 5:1.

8.3Females and Males of Reproductive Potential Sorafenib tablets may cause fetal harm when administered to a pregnant woman [ see Use in Specific Populations ( 8.1 )]. Pregnancy Testing Verify the pregnancy status of females of reproductive potential prior to the initiation of sorafenib tablets. Contraception Females Advise females of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of sorafenib tablets.

Males Based on genotoxicity and findings in animal reproduction studies, advise males with female partners of reproductive potential and pregnant partners to use effective contraception during treatment with sorafenib tablets and for 3 months following the last dose of sorafenib tablets [see Use in Specific Populations ( 8.1 ), Nonclinical Toxicology ( 13.1 )] . Infertility Males Based on findings in animal studies, sorafenib tablets may impair fertility in males of reproductive potential [see Nonclinical Toxicology ( 13.1 )] .

8.4Pediatric Use The safety and effectiveness of sorafenib tablets have not been established in pediatric patients. Juvenile Animal Toxicity Data Repeat dosing of sorafenib to young and growing dogs resulted in irregular thickening of the femoral growth plate at daily sorafenib doses ≥600 mg/m 2 (approximately 0.3 times the AUC at the recommended human dose), hypocellularity of the bone marrow adjoining the growth plate at 200 mg/m 2 /day (approximately 0.1 times the AUC at the recommended human dose), and alterations of the dentin composition at 600 mg/m 2 /day.

Sim…

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology ( 12.1 )] , sorafenib may cause fetal harm when administered to a pregnant woman. There are no available data in pregnant women to inform a drug-associated risk. In animal reproduction studies, oral administration of sorafenib to pregnant rats and rabbits during the period of organogenesis resulted in embryo-fetal toxicities at maternal exposures that were significantly lower than human exposures at the recommended dose of 400 mg twice daily (see Data).

Advise pregnant women and females of reproductive potential of the potential risk to a fetus. The background risk of major birth defects and miscarriage for 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.

Data Animal Data In animal reproduction studies, sorafenib was teratogenic and induced embryo-fetal toxicity (including increased post-implantation loss, resorptions, skeletal retardations, and retarded fetal weight) when administered orally to pregnant rats and rabbits during the period of organogenesis. The effects occurred at doses considerably below the recommended human dose of 400 mg twice daily (approximately 500 mg/m 2 /day on a body surface area basis). Adverse intrauterine development effects were seen at doses >0.2 .mg/kg/day (1.2 mg/m 2 /day) in rats and ≥0.3 mg/kg/day (≥3.6 mg/m 2 /day) in rabbits.

These doses result in exposures (AUC) that are approximately 0.008 times the AUC in patients at the recommended dose.

🧒 Pediatric Use 106 words ▾

8.4Pediatric Use The safety and effectiveness of sorafenib tablets have not been established in pediatric patients. Juvenile Animal Toxicity Data Repeat dosing of sorafenib to young and growing dogs resulted in irregular thickening of the femoral growth plate at daily sorafenib doses ≥600 mg/m 2 (approximately 0.3 times the AUC at the recommended human dose), hypocellularity of the bone marrow adjoining the growth plate at 200 mg/m 2 /day (approximately 0.1 times the AUC at the recommended human dose), and alterations of the dentin composition at 600 mg/m 2 /day.

Similar effects were not observed in adult dogs when dosed for 4 weeks or less.

🧓 Geriatric Use 88 words ▾

8.5Geriatric Use In total, 59% of HCC patients treated with sorafenib tablets were age 65 years or older and 19% were 75 and older. In total, 32% of RCC patients treated with sorafenib tablets were age 65 years or older and 4% were 75 and older. No differences in safety or efficacy were observed between older and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

🆘 Overdosage 61 words ▾

10 OVERDOSAGE The adverse reactions observed at a dose of 800 mg twice daily (2 times the recommended dose) were primarily diarrhea and dermatologic. No information is available on symptoms of acute overdose in animals because of the saturation of absorption in oral acute toxicity studies conducted in animals. In cases of suspected overdose, withhold sorafenib tablets and institute supportive care.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Sorafenib is a kinase inhibitor that decreases tumor cell proliferation in vitro. Sorafenib was shown to inhibit multiple intracellular (c-CRAF, BRAF and mutant BRAF) and cell surface kinases (KIT, FLT- 3, RET, RET/PTC, VEGFR-1, VEGFR-2, VEGFR-3, and PDGFR-ß). Several of these kinases are thought to be involved in tumor cell signaling, angiogenesis and apoptosis.

Sorafenib inhibited tumor growth of HCC, RCC, and DTC human tumor xenografts in immunocompromised mice. Reductions in tumor angiogenesis were seen in models of HCC and RCC upon sorafenib treatment, and increases in tumor apoptosis were observed in models of HCC, RCC, and DTC.

12.2Pharmacodynamics Cardiac Electrophysiology The effect of sorafenib tablets 400 mg twice daily on the QTc interval was evaluated in a multi-center, open-label, non-randomized trial in 53 patients with advanced cancer. No large changes in the mean QTc intervals (that is, >20 ms) from baseline were detected in the trial. After one 28-day treatment cycle, the largest mean QTc interval change of 8.5 ms (upper bound of two-sided 90% confidence interval, 13.3 ms) was observed at 6 hours post-dose on day 1 of cycle 2 [see Warnings and Precautions ( 5.9 ), Drug Interactions ( 7.3 )].

12.3Pharmacokinetics Multiple doses of sorafenib tablets for 7 days resulted in a 2.5- to 7-fold accumulation compared to a single dose. Steady-state plasma sorafenib concentrations were achieved within 7 days, with a peak-to-trough ratio of mean concentrations of less than 2. The steady-state concentrations of sorafenib following administration of sorafenib tablets 400 mg twice daily were evaluated in DTC, RCC and HCC patients.

Patients with DTC have mean steady-state concentrations that are 1.8-fold higher than patients with HCC and 2.3-fold higher than those with RCC. The reason for increased sorafenib concentrations in DTC patients is unknown. Mean C max and AUC increased less than proportionally beyond oral doses of 400 mg administered twice daily.

Absorption After administration of sorafenib tablets tablets, the mean relative bioavailability was 38 to 49% when compared to an oral solution. Following oral administration, sorafenib reached peak plasma levels in approximately 3 hours. Effects of Food With a moderate-fat meal (30% fat; 700 calories), bioavailability was similar to that in the fasted state.

With a high-fat meal (50% fat; 900 calories), bioavailability was reduced by 29% compared to that in the fasted state. Distribution In vitro binding of sorafenib to human plasma proteins was 99.5%. Elimination The mean elimination half-life of sorafenib was approximately 25 to 48 hours.

Metabolism Sorafenib undergoes oxidative metabolism by hepatic CYP3A4, as well as glucuronidation by UGT1A9. Excretion Sorafenib accounted for approximately 70 to 85% of the circulating analytes in plasma at steady-state. Eight metabolites of sorafenib have been identified, of which 5 have been detected in plasma.

The main circulating metabolite of sorafenib, the pyridine N-oxide that comprises approximately 9 to 16% of circulating analytes at steady-state, showed in vitro potency similar to that of sorafenib. Following oral administration of a 100 mg dose of a solution formulation of sorafenib, 96% of the dose was recovered within 14 days, with 77% of the dose excreted in feces and 19% of the dose excreted in urine as glucuronidated metabolites. Unchanged sorafenib, accounting for 51% of the dose, was found in feces but not in urine.

Specific Populations A study of the pharmacokinetics of sorafenib indicated that the mean AUC of sorafenib in Asians (N=78) was 30% lower than in Whites (N=40). Sex and age do not have a clinically meaningful effect on the pharmacokinetics of sorafenib. Patients with Renal Impairment Mild (CLcr 50 to 80 mL/min), moderate (CLcr 30 to <50 mL/min), and severe (CLcr <30 mL/min) renal impairment do not affect the pharmacokinetics of sorafenib [see Use in Spec…

🧬 Mechanism of Action 102 words ▾

12.1Mechanism of Action Sorafenib is a kinase inhibitor that decreases tumor cell proliferation in vitro. Sorafenib was shown to inhibit multiple intracellular (c-CRAF, BRAF and mutant BRAF) and cell surface kinases (KIT, FLT- 3, RET, RET/PTC, VEGFR-1, VEGFR-2, VEGFR-3, and PDGFR-ß). Several of these kinases are thought to be involved in tumor cell signaling, angiogenesis and apoptosis.

Sorafenib inhibited tumor growth of HCC, RCC, and DTC human tumor xenografts in immunocompromised mice. Reductions in tumor angiogenesis were seen in models of HCC and RCC upon sorafenib treatment, and increases in tumor apoptosis were observed in models of HCC, RCC, and DTC.

📦 How Supplied / Storage and Handling 77 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Sorafenib Tablets are supplied as 200 mg, round biconvex, red film-coated tablets, debossed with "F11" on one side and plain on the other side. Bottles of 30 NDC 13668-682-30 Bottles of 60 NDC 13668-682-60 Bottles of 120 NDC 13668-682-12 100 (10×10) unit-dose tablets NDC 13668-682-74 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Store in a dry place.

📋 Description 151 words ▾

11 DESCRIPTION Sorafenib, a kinase inhibitor, is the tosylate salt of sorafenib. Sorafenib tosylate has the chemical name 4-(4-{3-[4-Chloro-3-(trifluoromethyl)phenyl]ureido}phenoxy)- N 2 -methylpyridine-2 carboxamide mono(4-methylbenzenesulfonate). The molecular formula of sorafenib tosylate is C 21 H 16 ClF 3 N 4 O 3 x C 7 H 8 O 3 S and the molecular weight of sorafenib tosylate is 637.03 g/mole.

Its structural formula is: Sorafenib tosylate,USP is a White to slightly yellowish to brownish powder. Sorafenib tosylate is practically insoluble in aqueous media and in heptane, slightly soluble in ethanol. Sorafenib tablets, USP for oral use are supplied as film-coated tablets containing 200 mg sorafenib equivalent to 274 mg sorafenib tosylate, USP and the following inactive ingredients: croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, sodium lauryl sulphate, opadry 04F550007 Red.

Opadry 04F550007 Red contains Hypromellose, titanium dioxide, polyethylene glycol and ferric oxide red. FDA approved dissolution test specifications differ from USP. Structure

💬 Information for Patients ~2 min read ▾

17 PATIENTS COUNSELING INFORMATION Advise the patient to read FDA-approved patient labeling (Patient Information). Cardiovascular Events Discuss with patients that cardiac ischemia and/or infarction and congestive heart failure, have been reported during sorafenib tablets treatment, and that they should immediately report any episodes of chest pain or other symptoms of cardiac ischemia or congestive heart failure [see Warnings and Precautions ( 5.1 )]. Bleeding Inform patients that sorafenib tablets can increase the risk of bleeding and that they should promptly report any episodes of bleeding [see Warnings and Precautions ( 5.2 )].

Inform patients that bleeding or elevations in the International Normalized Ratio (INR) have been reported in some patients taking warfarin while on sorafenib tablets and that their INR should be monitored regularly [see Warnings and Precautions ( 5.6 )]. Hypertension Inform patients that hypertension can develop during sorafenib tablets treatment, especially during the first six weeks of therapy, and that blood pressure should be monitored regularly during treatment [see Warnings and Precautions ( 5.3 )]. Skin Reactions Advise patients of the possible occurrence of hand-foot skin reaction and rash during sorafenib tablets treatment and appropriate countermeasures [see Warnings and Precautions ( 5.4 )].

Gastrointestinal Perforation Advise patients that cases of gastrointestinal perforation have been reported in patients taking sorafenib tablets [see Warnings and Precautions ( 5.5 )]. Risk of Impaired Wound Healing Advise patients that sorafenib tablets may impair wound healing. Advise patients to inform their healthcare provider of any planned surgical procedure [see Warnings and Precautions ( 5.7 )] .

QT Interval Prolongation Inform patients with a history of prolonged QT interval that sorafenib tablets can worsen the condition [see Warnings and Precautions ( 5.9 ) and Clinical Pharmacology ( 12.2 )] . Drug-Induced Liver Injury Inform patients that sorafenib tablets can cause hepatitis which may result in hepatic failure and death. Advise patients that liver function tests should be monitored regularly during treatment and to report signs and symptoms of hepatitis [see Warnings and Precautions ( 5.10 )].

Embryo-Fetal Toxicity Advise females to inform their healthcare provider if they are pregnant or become pregnant. Inform female patients of the risk to a fetus and potential loss of pregnancy [see Use in Specific Populations ( 8.1 )]. Advise females of reproductive potential to use effective contraception during treatment with sorafenib tablets and for 6 months after the last dose.

Advise male patients with female partners of reproductive potential or who are pregnant to use effective contraception during treatment with sorafenib tablets and for 3 months after receiving the last dose of sorafenib tablets [see Warnings and Precautions ( 5.11 ), Use in Specific Populations ( 8.1 , 8.3 )]. Lactation Advise patients not to breastfeed while taking sorafenib tablets and for 2 weeks after receiving the last dose of sorafenib tablets [see Use in Specific Populations ( 8.2 )]. Missed Doses Instruct patients that if a dose of sorafenib tablets is missed, the next dose should be taken at the regularly scheduled time, and not double the dose.Instruct patients to contact their healthcare provider immediately if they take too much sorafenib tablets.

Trademarks are the property of their respective owners. Manufactured by: TORRENT PHARMACEUTICALS LTD., INDIA. Manufactured For: TORRENT PHARMA INC., Basking Ridge, NJ 07920.

8103520 Revised: December 2025 Torrent logo 1

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