Stivarga

Stivarga is a prescription-only medicine used to treat patients with treatment-resistant metastatic (cancer that has spread).

• Colorectal cancer.
• Gastrointestinal Stromal Tumors (GIST), an uncommon tumor of the gastrointestinal tract.

It is available in a tablet form.

Before using Stivarga, you must know all about the risks and complications associated with it. Together with your doctor, you can decide whether the medication will do you more goods than the harms.

Here are some factors to be considered before deciding to use this medicine:

Allergies: Inform your doctor about the allergies you have, such as to this medication, other medications, or to foods, dyes, or preservatives.

Pediatric: Safety and efficacy of regorafenib in children have not been well documented. Consult your child’s doctor before using in your children.

Geriatric: It is generally safe for use in elderly.

Pregnancy: It falls under pregnancy category D for all trimesters meaning that taking this medicine during pregnancy is risky to the baby, but benefits of its use in a life-threatening situation may be significantly greater than the potential risks.

Breastfeeding: It may be used in a nursing mother after assessing risks and benefits of the use.

Drug Interactions: Taking two medicines together can be harmful due to possible interactions. In other cases, even if there is a possible interaction between two medicines your doctor may advise you to take them together after adjusting the dose or issuing precautions.

The following medicine is generally not recommended to be used with regorafenib. Inform your doctor if you are using eletriptan.

Though usually not recommended, your doctor may decide, after adjusting dose or frequency of one or both medicines, to use this medicine with any of the following medicines:

• Amiodarone
• Atazanavir
• Bupropion
• Carbamazepine
• Ceritinib
• Cilostazol
• Clarithromycin
• Clozapine
• Cobicistat
• Conivaptan
• Crizotinib
• Dabrafenib
• Doxorubicin
• Eliglustat
• Enzalutamide
• Fentanyl
• Fosphenytoin
• Idelalisib
• Itraconazole
• Ketoconazole
• Nefazodone
• Nilotinib
• Ospemifene
• Oxycodone
• Phenytoin
• Piperaquine
• Posaconazole
• Rifabutin
• Rifampin
• Rifapentine
• Saquinavir
• St John's Wort
• Telithromycin
• Voriconazole

Other Interactions: Taking your medicine together with certain foods or items such as alcohol or tobacco may cause undesirable interactions. Talk to your doctor to know if using this medicine with food, alcohol, or tobacco is safe. Avoid taking grapefruit or its juice while using regorafenib.

Inform your doctor if you have any of the following conditions:

• Bleeding disorders
• Heart problems
• Hypertension: Use cautiously
• Liver disease: Use cautiously

Proper usage of Stivarga requires strict adherence to your doctor’s orders. Cancer medicines are very potent and can cause a range of side effects. Therefore, you need to work together with your doctor to minimize the side effects and optimize the outcome.

• Follow your doctor’s instructions and do not take more, less, more frequently or for a longer duration than recommended.
• Read the package insert carefully and follow accordingly. For any query, consult your doctor.
• Swallow the entire tablet with enough water instead of crushing or chewing it.
• Maintain a regular schedule of intake and take with a low-fat meal.
• Avoid taking grapefruit or its juice during treatment with regorafenib.

Dosing: For best results, follow your doctor to know what amount of medicine you should take in a single dose. The doses of a medicine can differ according to the conditions for which it is being prescribed.

Remember your doses can differ. Consult your doctor if you have anything to ask. The doses of tablets are:

For metastatic colorectal cancer:

• Adults: Take four 40 mg tablets (Total: 160 mg) once daily for 21 days of each 28-day cycle. Your doses may be adjusted if needed.
• Children: Your doctor will decide the use and dose.

For metastatic gastrointestinal stromal tumors (GIST):

• Adults: Take four 40 mg tablets (Total: 160 mg) once daily for 21 days of each 28-day cycle. Your doses may be adjusted if needed.
• Children: Your doctor will decide the use and dose.

Missed Dose: Take your missed dose once you remember but avoid it if it’s time to take your next dose, and follow your normal dosing schedule. Avoid taking double doses to make up for the missed dose. Do not miss more than a dose. If you do, call your doctor before restarting it.

Storage:

• Store in a closed container at room temperature.
• Keep away from heat, moisture, and direct light.
• Do not freeze.
• Keep away from children.
• Discard any unused or expired medicines.

Before using Stivarga, there are some precautions you must take. Your progress should be regularly monitored to determine if you are responding to the treatment or have undesirable side effects.

Call your doctor immediately if you have symptoms:

• Associated with changes in blood pressure such as a severe headache, dizziness, or vision problems.
• Of severe liver impairment such as the tender upper stomach, clay-colored stools, darker than normal color of urine, decreased appetite, nausea, vomiting, or yellowish skin or eyes.
• Like red, painful skin, blisters, bleeding, or swollen palms and soles, indicating severe skin conditions such as hand-foot skin reaction.
• Of serious heart conditions such as chest pain radiating to your arms, jaw, back, or neck, breathing difficulties, sweating, or vomiting.
• Indicating an uncommon brain problem, reversible posterior leukoencephalopathy syndrome (RPLS), including a headache, fits, confusion, or blurry vision.

Since you are at increased risk of bleeding or bruising while taking this medicine, Take care not to get yourself any cut or injury.

Do not get pregnant while using this medicine. If you suspect a pregnancy during or 2 months after completion of therapy, consult your doctor immediately.

Inform your doctor about your intake of this medicine before going for any kind of surgery. Consult your doctor before using any prescription or nonprescription medicines and herbal or vitamin supplements.

Consult your doctor immediately if you experience any of the following side effects using Stivarga:

More common: 

• Bleeding from gums or nose
• Blurry vision
• A cough or hoarseness
• Coughing up blood (hemoptysis)
• Breathing or swallowing problems
• Dizziness
• Fever
• Chills
• Headache
• Excessive menstrual discharge
• Pain in lower back or side
• Nervousness
• Pain during urination
• Thumping sound in the ears
• Longer than normal bleeding from cuts
• Rash
• Bloody or black, tar-like stools
• Red, swollen, or painful skin
• Irregular heartbeats
• Tingling sensation in the limbs
• Skin ulcers

Less common:

• Pain in chest, arms, jaw, back, or neck
• Concentrated urine
• Generalized weakness
• Clay-colored stools
• Nausea or vomiting
• Trembling legs, arms, hands, or feet
• Continuous stomach pain
• Sweating
• Yellowing of the eyes or skin

Rare:

• Confusion
• Burning in the chest
• Dyspepsia
• Severe pain or cramps in stomach
• Vomit that is similar to coffee grounds

Mild and non-serious side effects usually go away on their own without requiring medical intervention. You may also ask your doctor to learn more about how you may prevent or reduce the side effects.

Talk to your doctor if the side effects persist or worry you, including:

More common: 

• Altered taste
• Loss or thinning of hair
• Weakness
• Stiff muscle or joint
• Weight loss

Less common:

• Constipation
• Mental depression
• Skin and hair dryness
• Abnormal muscle tone
• Weight gain

The side effects of the medicine are not limited to the ones listed above. Call your doctor immediately if you experience any side effects that are uncommon or worry you. To report side effects to the FDA, contact at 1-800-FDA-1088.