sorafenib 200 mg/1
sorafenib · TABLET, FILM COATED · Golden State Medical Supply, Inc.
sorafenib is a tablet, film coated containing sorafenib at 200 mg/1, taken oral. Manufactured by Golden State Medical Supply, Inc..
Key Facts
- Brand Name
- sorafenib
- Generic Name
- sorafenib
- NDC Code (Product)
51407-760- Manufacturer
- Golden State Medical Supply, Inc.
- Strength
- 200 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA209050
- Drug Class
- Kinase Inhibitor [EPC]
- Marketing Start
- 11/09/2022
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Sorafenib tablets are a kinase inhibitor indicated for the treatment of Unresectable hepatocellular carcinoma(1.1) Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refractory to radioactive iodine treatment (1.3) 1.1 Hepatocellular Carcinoma Sorafenib tablets are indicated for the treatment of patients with unresectable hepatocellular carcinoma (HCC). 1.3 Differentiated 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 & Administration
•The recommended dosage is 400 mg orally twice daily without food. (2.1) 2.1 Recommended Dosage The recommended dosage of sorafenib tablets is 400 mg orallytwice daily without food (at least 1 hourbefore or 2 hours after a meal) until the patient is no longer clinically benfiting from therapy or untilunacceptable toxicity. 2.2 Dose 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 forAdverse Reactions Dose Reduction Hepatocellular 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 T ablets Dosage M odification Cardiovascular Events [see Warnings and Precautions (5.1…
Contraindications
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 is contraindicated in patients with squamous cell lung cancer. (4) 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 are contraindicated in patients with squamous cell lung cancer [see Warnings and Precautions (5.8)].
Drug Interactions
Strong CYP3A Inducers: Avoid strong CYP3A4 inducers.(7.1) 7.1 Effect of Other Drugs on Sorafenib Tablets Strong CYP3A4 Inducers The concomitant use of sorafenib tablets 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 tablets with strong CYP3A4 inducers, when possible, because these drugs can decrease the systemic exposure to sorafenib. Neomycin The concomitant use of sorafenib tablets with neomycin decreased the mean AUC of sorafenib, which may decrease the antitumor activity. Avoid concomitant use of sorafenib tablets with neomycin. The effects of other antibiotics on the pharmacokinetics of sorafenib have not been studied [see Clinical Pharmacology (12.3)]. 7.2 Concomitant Use of Warfarin The concomitant use of sorafenib tablets 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 tablets [see Warnings and Precautions (5.6)]. 7.3 Drugs That Prolong the QT Interval Sorafenib tablets are associated with QTc interval prolongation…
Adverse Reactions
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 Yabao Pharmaceutical Co., Ltd. Beijing at 914-656-3049 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 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 )] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug ca…
Frequently Asked Questions
What is sorafenib used for?
sorafenib contains sorafenib. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is sorafenib a controlled substance?
sorafenib is not classified as a controlled substance by the DEA.
What is the generic name for sorafenib?
The generic name for sorafenib is sorafenib. There are 5 other brand versions of sorafenib.
What is the NDC code for sorafenib 200 mg/1?
The NDC (National Drug Code) for sorafenib 200 mg/1 is 51407-760, listed by Golden State Medical Supply, Inc..