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Medically reviewed by Oliinyk Elizabeth Ivanovna, PharmD. Last updated on 23.04.2022
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Hepatocellular Carcinoma
Soranib® is indicated for the treatment of patients with unresectable hepatocellular carcinoma (HCC).
Renal Cell Carcinoma
Soranib is indicated for the treatment of patients with advanced renal cell carcinoma (RCC).
Differentiated Thyroid Carcinoma
Soranib is indicated for the treatment of patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) that is refractory to radioactive iodine treatment.
Soranib (Soranib) is a cancer medication that interferes with the growth and spread of cancer cells in the body.
Soranib is used to treat liver cancer, thyroid cancer, or a type of kidney cancer called advanced renal cell carcinoma.
Soranib may also be used for purposes not listed in this medication guide.
The recommended daily dose of Soranib is 400 mg (2 x 200 mg tablets) taken twice daily without food (at least 1 hour before or 2 hours after a meal). Treatment should continue until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity occurs.
Management of suspected adverse drug reactions may require temporary interruption and/or dose reduction of Soranib. When dose reduction is necessary, the Soranib dose may be reduced to 400 mg once daily. If additional dose reduction is required, Soranib may be reduced to a single 400 mg dose every other day.
Suggested dose modifications for skin toxicity are outlined in Table 1.
Table 1: Suggested Dose Modifications for Skin Toxicity
| Skin Toxicity Grade | Occurrence | Suggested Dose Modification |
| Grade 1: Numbness, dysesthesia, paresthesia, tingling, painless swelling, erythema or discomfort of the hands or feet which does not disrupt the patient's normal activities | Any occurrence | Continue treatment with Soranib and consider topical therapy for symptomatic relief |
| Grade 2: Painful erythema and swelling of the hands or feet and/or discomfort affecting the patient's normal activities | 1st occurrence | Continue treatment with Soranib and consider topical therapy for symptomatic relief If no improvement within 7 days, see below |
| No improvement within 7 days or 2nd or 3rd occurrence | Interrupt Soranib treatment until toxicity resolves to Grade 0–1 When resuming treatment, decrease Soranib dose by one dose level (400 mg daily or 400 mg every other day) | |
| 4th occurrence | Discontinue Soranib treatment | |
| Grade 3: Moist desquamation, ulceration, blistering or severe pain of the hands or feet, or severe discomfort that causes the patient to be unable to work or perform activities of daily living | 1st or 2nd occurrence | Interrupt Soranib treatment until toxicity resolves to Grade 0–1 When resuming treatment, decrease Soranib dose by one dose level (400 mg daily or 400 mg every other day) |
| 3rd occurrence | Discontinue Soranib treatment |
No dose adjustment is required on the basis of patient age, gender, or body weight.
Concomitant strong CYP3A4 inducers
Avoid concomitant use of strong CYP3A4 inducers (such as, carbamazepine, dexamethasone, phenobarbital, phenytoin, rifampin, rifabutin, St. John's wort), when possible, because inducers can decrease the systemic exposure to Soranib.
How supplied
Dosage Forms And Strengths
Tablets containing Soranib (274 mg) equivalent to 200 mg of Soranib.
Soranib tablets are round, biconvex, red film-coated tablets, debossed with the “Bayer cross” on one side and “200” on the other side.
Storage And Handling
Soranib tablets are supplied as round, biconvex, red film-coated tablets, debossed with the “Bayer cross” on one side and “200” on the other side, each containing Soranib equivalent to 200 mg of Soranib.
Bottles of 120 tablets NDC 50419-488-58
Storage
Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F). Store in a dry place.
Manufactured for: Bayer HealthCare Pharmaceuticals Inc., Wayne, NJ 07470. Manufactured in Germany Onyx Pharmaceuticals, Inc., 249 East Grand Avenue, South San Francisco, CA 94080. Distributed and marketed by: Bayer HealthCare Pharmaceuticals Inc., Wayne, NJ 07470. Marketed by: Onyx Pharmaceuticals, Inc. 249 East Grand Avenue, South San Francisco, CA 94080. Revised: 10/2013
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What is the most important information I should know about Soranib?
Do not use Soranib if you are pregnant. It could harm the unborn baby. Use effective birth control while you are using this medication and for at least 2 weeks after your treatment ends, whether you are a man or a woman. Soranib use by either parent may cause birth defects.
Do not breast-feed while using this medication.
You should not use Soranib if you are allergic to it, or if you have squamous cell lung cancer and you are being treated with carboplatin (Paraplatin) and paclitaxel (Onxol, Taxol, Abraxane).
Before you take Soranib, tell your doctor if you have kidney or liver problems (other than cancer), a bleeding or blood clotting disorder, high blood pressure, heart disease, slow heartbeats, congestive heart failure, a personal or family history of Long QT syndrome, a history of stroke or heart attack, or any allergies.
There are many other drugs that can interact with Soranib. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
If you need surgery or dental work, tell the surgeon or dentist ahead of time that you are taking Soranib.
Use Soranib as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Soranib. Talk to your pharmacist if you have questions about this information.
- Take Soranib on an empty stomach at least 1 hour before or 2 hours after eating.
- Swallow Soranib whole. Do not break, crush, or chew before swallowing.
- Take Soranib with a full glass of water (8 oz [240 mL]).
- Continue to take Soranib even if you feel well. Do not miss any doses.
- If you miss a dose of Soranib, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Soranib.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Use: Labeled Indications
Hepatocellular cancer: Treatment of unresectable hepatocellular cancer (HCC)
Renal cell cancer, advanced: Treatment of advanced renal cell cancer (RCC)
Thyroid cancer, differentiated: Treatment of locally recurrent or metastatic, progressive, differentiated thyroid cancer (refractory to radioactive iodine treatment)
Off Label Uses
Angiosarcoma (recurrent or metastatic)
Data from a phase II sarcoma study which included patients with angiosarcoma supports the use of Soranib in the treatment of angiosarcoma.
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What other drugs will affect Soranib?
CYP3A4 Inducers: CYP1A2 and CYP3A4 activities were not altered after treatment of cultured human hepatocytes with Soranib, indicating that Soranib is unlikely to be an inducer of CYP1A2 and CYP3A4. Continuous concomitant administration of Soranib and rifampicin resulted in an average 37% reduction of Soranib AUC. Other inducers of CYP3A4 activity (eg, Hypericum perforatum also known as St. John's wort, phenytoin, carbamazepine, phenobarbital and dexamethasone) may also increase metabolism of Soranib and thus decrease Soranib concentrations.
CYP3A4 Inhibitors: Ketoconazole, a potent inhibitor of CYP3A4, administered once daily for 7 days to healthy male volunteers did not alter the mean AUC of a single 50-mg dose of Soranib. Therefore, clinical pharmacokinetic interactions of Soranib with CYP3A4 inhibitors are unlikely.
CYP2C9 Substrates: The possible effect of Soranib on warfarin, a CYP2C9 substrate, was assessed in Soranib-treated patients compared to placebo-treated patients. The concomitant treatment with Soranib and warfarin did not result in changes in mean PT-INR compared to placebo. However, patients taking warfarin should have their INR checked regularly.
CYP Isoform-Selective Substrates: Concomitant administration of midazolam, dextromethorphan and omeprazole, which are substrates of cytochromes CYP3A4, CYP2D6 and CYP2C19, respectively, following 4 weeks of Soranib administration did not alter the exposure of these agents. This indicates that Soranib is neither an inhibitor nor an inducer of these cytochrome P-450 isoenzymes. In a separate clinical study, concomitant administration of Soranib with paclitaxel resulted in an increase, instead of a decrease, in the exposure of 6-OH paclitaxel, the active metabolite of paclitaxel that is formed by CYP2C8. These data suggest that Soranib may not be an in vivo inhibitor of CYP2C8. In another clinical study, concomitant administration of Soranib with cyclophosphamide resulted in a small decrease in cyclophosphamide exposure, but no decrease in the systemic exposure of 4-OH cyclophosphamide, the active metabolite of cyclophosphamide that is formed primarily by CYP2B6. These data suggest that Soranib may not be an in vivo inhibitor of CYP2B6.
Combination with Other Antineoplastic Agents: In clinical studies, Soranib has been administered together with a variety of other antineoplastic agents at their commonly used dosing regimens, including gemcitabine, cisplatin, oxaliplatin, paclitaxel, carboplatin, capecitabine, doxorubicin, docetaxel, irinotecan and cyclophosphamide. Soranib had no clinically relevant effect on the pharmacokinetics of gemcitabine, cisplatin, carboplatin, oxaliplatin, or cyclophosphamide.
Paclitaxel/Carboplatin: Administration of paclitaxel (225 mg/m2) and carboplatin (AUC=6) with Soranib (≤400 mg twice daily), administered with a 3-day break in Soranib dosing around administration of paclitaxel/carboplatin, resulted in no significant effect on the pharmacokinetics of paclitaxel.
Co-administration of paclitaxel (225 mg/m2, once every 3 weeks) and carboplatin (AUC=6) with Soranib (400 mg twice daily, without a break in Soranib dosing) resulted in a 47% increase in Soranib exposure, a 29% increase in paclitaxel exposure and a 50% increase in 6-OH paclitaxel exposure. The pharmacokinetics of carboplatin were unaffected.
These data indicate no need for dose adjustments when paclitaxel and carboplatin are co-administered with Soranib with a 3-day break in Soranib dosing. The clinical significance of the increases in Soranib and paclitaxel exposure, upon co-administration of Soranib without a break in dosing, is unknown.
Capecitabine: Co-administration of capecitabine (750-1050 mg/m2 twice daily, days 1-14 every 21 days) and Soranib (200 or 400 mg twice daily, continuous uninterrupted administration) resulted in no significant change in Soranib exposure, but a 15-50% increase in capecitabine exposure and a 0-52% increase in 5-FU exposure. The clinical significance of these small to modest increases in capecitabine and 5-FU exposure when co-administered with Soranib is unknown.
Doxorubicin/Irinotecan: Concomitant treatment with Soranib resulted in a 21% increase in the AUC of doxorubicin. When administered with irinotecan, whose active metabolite SN-38 is further metabolized by the UGT1A1 pathway, there was a 67-120% increase in the AUC of SN-38 and a 26-42% increase in the AUC of irinotecan. The clinical significance of these findings is unknown.
Docetaxel (75 or 100 mg/m2 administered once every 21 days) when co-administered with Soranib (200 mg twice daily or 400 mg twice daily administered on day 2 through 19 of a 21-day cycle), with a 3-day break in dosing, around administration of docetaxel, resulted in a 36-80% increase in docetaxel AUC and a 16-32% increase in docetaxel Cmax. Caution is recommended when Soranib is co-administered with docetaxel.
Combination with Antibiotics: Co-administration of neomycin, a non-systemic antimicrobial agent used to eradicate gastrointestinal flora, interferes with the enterohepatic recycling of Soranib, resulting in decreased Soranib exposure. In healthy volunteers treated with a 5-day regimen of neomycin the average bioavailability of Soranib decreased by 54%. The clinical significance of these findings is unknown. Effects of other antibiotics have not been studied, but will likely depend on their ability to decrease glucuronidase activity.
Combination with Proton-Pump Inhibitors: Omeprazole: Co-administration of omeprazole has no impact on the pharmacokinetics of Soranib. No dose adjustment for Soranib is necessary.
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What are the possible side effects of Soranib?
The most important serious adverse reactions were myocardial infarction/ischemia, gastrointestinal perforation, drug-induced hepatitis, hemorrhage, and hypertension/hypertensive crisis.
The most common adverse reactions were diarrhea, rash, alopecia and hand-foot skin syndrome (corresponds to palmar-plantar erythrodysesthesia syndrome in MedDRA).
Adverse reactions reported in multiple clinical trails or through post-marketing use are listed in Table 3 and 4, by system organ class (in MeDRA) and frequency. Frequencies are defined as: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), not known (cannot be estimated from the data available).
Within each frequency grouping, adverse effects are presented in order of decreasing seriousness.
Palmar-plantar erythrodysesthesia syndrome in MedDRA.
Adverse reactions that occurred either during clinical studies or have been identified through post-marketing use are listed in Table 5, by system organ class (in MedDRA) and frequency. Frequencies are defined as: Very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10,000, <1/1000), not known (cannot be estimated from the data available).
Within each frequency grouping, adverse effects are presented in order of decreasing seriousness.
Congestive Heart Failure: In company sponsored clinical trials, congestive heart failure was reported as an adverse event in 1.9% of patients treated with Soranib (N=2276). In Study 11213 (RCC) adverse events consistent with congestive heart failure were reported 1.7% of those treated with Soranib and 0.7% receiving placebo. In Study 100554 (HCC), 0.99% of those treated with Soranib and in 1.1% receiving placebo were reported with these events.
Special Populations: Two randomized placebo-controlled trials comparing safety and efficacy of Soranib in combination with doublet platinum-based chemotherapies (carboplatin/paclitaxel and separately gemcitabine/cisplatin) versus the respective doublet platinum-based chemotherapies alone as 1st line treatment for patients with advanced non-small cell lung cancer (NSCLC) did not meet their primary endpoint of improved overall survival. Safety events were generally consistent with those previously reported. However, in both trials, higher mortality was observed in the subset of patients with squamous cell carcinoma of the lung treated with Soranib and doublet platinum-based chemotherapies versus those treated with doublet platinum-based chemotherapies alone (Paclitaxel/Carboplatin: HR 1.81, 95% CI 1.19-2.74; Gemcitabine/Cisplatin: HR 1.22, 95% CI 0.82-1.8). No definitive cause was identified for the findings.
Safety was also assessed in a phase 2 study pool comprised of 638 Soranib-treated patients, including 202 patients with RCC, 137 patients with hepatocellular carcinoma, and 299 patients with other cancers. The most common drug-related adverse events reported in Soranib-treated patients in this pool were rash (38%), diarrhea (37%), hand-foot skin reaction (35%), and fatigue (33%). The respective rates of CTC (v 2.0) grade 3 and 4 drug-related adverse events in Soranib-treated patients were 37% and 3%, respectively.
Laboratory Test Abnormalities in RCC Patients (Study 11213): Elevated lipase and amylase levels were very commonly reported. In Study 11213, Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or 4 lipase elevations occurred in 12% of patients in the Soranib group compared to 7% of patients in the placebo group. CTCAE grade 3 or 4 amylase elevations were reported in 1% of patients in the Soranib group compared to 3% of patients in the placebo group. Clinical pancreatitis was reported in 2/451 Soranib-treated patients (CTCAE grade 4) and 1/451 patients (CTCAE grade 2) in the placebo group in Study 1.
Hypophosphatemia was a common laboratory finding, observed in 45% of Soranib treated patients compared to 11% of placebo patients. CTCAE grade 3 hypophosphatemia (1-2 mg/dL) occurred in 13% on Soranib treated patients and 3% of patients in the placebo group. There were no cases of CTCAE grade 4 hypophosphatemia (<1 mg/dL) reported in either Soranib or placebo patients. The etiology of hypophosphatemia associated with Soranib is not known.
CTCAE grade 3 or 4 were reported for lymphopenia in 13% of Soranib treated patients and 7% of placebo patients, for neutropenia in 5% of Soranib treated patients and 2% of placebo patients, for anemia in 2% of Soranib treated patients and 4% of placebo patients and for thrombocytopenia in 1% of Soranib treated patients and 0% of placebo patients.
Hypocalcemia was reported in 12% of Soranib treated patients compared to 7.5% of placebo patients. Most reports of hypocalcemia were low grade (CTCAE grade 1 and 2). CTCAE grade 3 hypocalcemia (6-7 mg/dL) occurred in 1.1% of Soranib treated patients and 0.2% of patients in the placebo group, and CTCAE grade 4 hypocalcemia (<6 mg/dL) occurred in 1.1% of Soranib treated patients and 0.5% of patients in the placebo group. The etiology of hypocalcemia associated with Soranib is not known.
Laboratory Test Abnormalities in HCC Patients (Study 100554): Elevated lipase was observed in 40% of patients treated with Soranib compared to 37% of patients in the placebo group. CTCAE grade 3 or 4 lipase elevations occurred in 9% of patients in each group. Elevated amylase was observed in 34% of patients treated with Soranib compared to 29% of patients in the placebo group. CTCAE grade 3 or 4 amylase elevations were reported in 2% of patients in each group. Many of the lipase and amylase elevations were transient, and in the majority of cases, Soranib treatment was not interrupted. Clinical pancreatitis was reported in 1 of 297 Soranib-treated patients (CTCAE grade 2).
Hypophosphatemia was a common laboratory finding, observed in 35% of Soranib-treated patients compared to 11% of placebo patients; CTCAE grade 3 hypophosphatemia (1-2 mg/dL) occurred in 11% of Soranib-treated patients and 2% of patients in the placebo group; there was 1 case of CTCAE grade 4 hypophosphatemia (<1 mg/dL) reported in the placebo group. The etiology of hypophosphatemia associated with Soranib is not known.
Elevations in liver function tests were comparable between the 2 arms of the study. Elevated AST was observed in 94% of Soranib-treated patients and 91% of placebo patients; CTCAE grade 3 or 4 AST elevations were reported in 16% of Soranib-treated patients and 17% of patients in the placebo group. ALT elevations were observed in 69% of Soranib-treated patients and 68% of placebo patients; CTCAE grade 3 or 4 ALT elevations were reported in 3% of Soranib-treated patients and 8% of placebo treated patients. Elevated bilirubin was observed in 47% of Soranib-treated patients and 45% of placebo patients; CTCAE grade 3 or 4 bilirubin elevations were reported in 10% of Soranib-treated patients and 11% of placebo treated patients. Hypoalbuminemia was observed in 59% of Soranib-treated patients and 47% of placebo patients; no CTCAE grade 3 or 4 hypoalbuminemia was observed in either group.
Alkaline phosphatase elevations were observed in 82.2% of Soranib-treated patients and 82.5% of placebo patients; CTCAE grade 3 alkaline phosphatase elevations were reported in 6.2% of Soranib-treated patients and 8.2% of placebo treated patients; no CTCAE grade 4 alkaline phosphatase elevation was observed in either group.
International normalized ratio elevations were observed in 42% of Soranib-treated patients and 34% of placebo patients; CTCAE grade 3 INR elevations were reported in 4% of Soranib-treated patients and 2% of placebo patients; there was no CTCAE grade 4 INR elevation in either group.
Lymphopenia was observed in 47% of Soranib-treated patients and 42% of placebo patients; CTCAE grade 3 or 4 lymphopenia was reported in 6% of patients in each group. Neutropenia was observed in 11% of Soranib-treated patients and 14% of placebo patients; CTCAE grade 3 or 4 neutropenia was reported in 1% of patients in each group.
Anemia was observed in 59% of Soranib-treated patients and 64% of placebo patients; CTCAE grade 3 or 4 anemia was reported in 3% of patients in each group.
Thrombocytopenia was observed in 46% of Soranib-treated patients and 41% of placebo patients; CTCAE grade 3 or 4 thrombocytopenia was reported in 4% of Soranib-treated patients and <1% of placebo patients.
Hypocalcaemia was reported in 26.5% of Soranib-treated patients compared to 14.8% of placebo patients. Most reports of hypocalcemia were low grade (CTCAE grade 1 and 2). CTCAE grade 3 hypocalcemia (6-7 mg /dL) occurred in 1.8% of Soranib-treated patients and 1.1% of patients in the placebo group, and CTCAE grade 4 hypocalcemia (<6 mg/dL) occurred in 0.4% of Soranib-treated patients and 0% of patients in the placebo group. The etiology of hypocalcemia associated with Soranib is not known.
Each tablet contains Sorafenib 200 mg (Soranib 274 mg).
Soranib also contains the following excipients: Tablet Core: Croscarmellose sodium, microcrystalline cellulose, hydroxypropylmethyl cellulose, sodium lauryl sulfate magnesium stearate. Film-Coating: Hydroxypropylmethyl cellulose, macrogol, titanium dioxide, red iron oxide
Soranib is 4-(4-{3-[4-Chloro-3-(trifluoromethyl)phenyl]-ureido}phenoxy)-N2-methylpyridine-2-carboxamide 4-methylbenzenesulfonate. Its empirical formula is C21H16ClF3N4O3 x C7H8O3S and molecular weight is 637 g/mole.
Soranib is a white to yellowish or brownish solid. It is practically insoluble in aqueous media, slightly soluble in ethanol and soluble in PEG 400.