Sutenamo 50 Capsule

Description of Sutenamo (Sunitinib 50mg) capsule

Sunitinib belongs to a class of medications known as anti-cancer drugs, and is given by mouth and used to treat some types of adult cancer. It is a member of the family of multi-targeted receptor Tyrosine Kinase Inhibitors (TKIs), which has its antineoplastic effect inhibiting a variety of receptor tyrosine kinases that mediate tumour growth, angiogenesis and metastatic progression. The drug stops the growth of tumours by interfering with the vascular endothelial growth factor receptors (VEGFRs), platelet-derived growth factor receptors (PDGFRs) and other kinases which are highly crucial in the survival and growth of tumours.

Indications of Sutenamo (Sunitinib 50mg) capsule

The most common Sunitinib indications are in the treatment of advanced renal cell carcinoma (RCC), imatinib-resistant or imatinib-intolerant gastrointestinal stromal tumours (GIST) and progressive as well as well-differentiated neuroendocrine tumours of the pancreas (pNET) in patients with unresectable locally advanced or metastatic disease. The doctor prescribes the drug after he or she has analyzed the disease, and can decide that the disease has progressed beyond that or surgery has been unsuccessful in eradicating the disease.

Mechanism of action of Sutenamo (Sunitinib 50mg) capsule

Sunitinib is a multi-targeted receptor tyrosine kinase (VEGFRs (1, 2, 3), PDGFRs (alpha and betas), KIT, FLT3Rs CF-1R and RET). It inhibits angiogenesis and oxygenation of tumours, causes apoptosis of the tumour cells as well as blocks proliferative signalling pathways upon which the survival of the cancer cells relies on.

How to consume Sutenamo (Sunitinib 50mg) capsule

Patients are supposed to take Sunitinib in accordance with their clinician schedule, dose and duration. The drug can be used either with or without food and once per day at the same time. Capsules are to be swallowed whole and not crushed, opened or chewed. The normal course regime is 4 weeks of daily dose then 2 weeks of no treatment (4/2 regime) unless otherwise directed by the physician.

Side Effects of Sutenamo (Sunitinib 50mg) capsule

1. Common side effects

• Fatigue or weakness
• Diarrhoea and nausea
• Hypertension
• Hand-foot syndrome (palmar-plantar erythrodysaesthesia)
• Mucositis and stomatitis
• Skin discolouration (yellow tinge)

2. Serious side effects

• Heart failure and lessening ejection fraction of the left ventricle.
• Hepatotoxicity and hepatofailure.
• Haemorrhage and thromboembolism.
• Severe hypertension and hypertensive crisis.

3. Rare side effects

• Osteonecrosis of the jaw
• Tumour lysis syndrome
• Reversible posterior leukoencephalopathy syndrome (RPLS)

Safety Advice for Sutenamo (Sunitinib 50mg) capsule

Periodically, clinical monitoring of Sunitinib patients (complete blood count (neutrophils, erythrocytes, platelets), hepatic and renal functional tests, blood pressure, and cardiac tests) should be carried out to diagnose the development of adverse effects.

Breastfeeding: Sunitinib has contraindication during lactation as the drug and its metabolites can enter breast milk and lead to harm to the baby who is breast-feeding.

Pregnancy: Pregnancy is contraindicated with sunitinib which is likely to be teratogenic. Women who have potential childbearing should be on effective birth control during treatment and at least 4 weeks of the final dose and needs guidance on the birth control methods used by their clinician.

Alcohol: Intake of alcohol should be limited as it could potentiate hepatotoxicity associated with Sunitinib therapy.

Liver: Previously patients with hepatic disorders must take sunitinib cautiously and under stringent medical attention as the drug may increase the hepatic enzymes and lead to hepatotoxicity.

Lungs: The doctor should report of a new cough, dyspnoea or chest pain immediately.

Kidney: Patients with severe cases of renal failure would need to be attended to.

Driving: If the patient feels dizzy and they should not drive or operate heavy equipment

Interaction of Sutenamo (Sunitinib 50mg) capsule

• Drug-Drug Interaction :

Ketoconazole x Sunitinib

Administer with caution or reduce dose, because strong CYP3A4 inhibitors like ketoconazole could elevate plasma levels of Sunitinib thus increasing the likelihood of adverse effects.

Rifampicin x Sunitinib

Where feasible, use an alternative drug since strong CYP3A4 inducers like rifampicin can greatly lower plasma levels of Sunitinib lowering its therapeutic effect.

Warfarin x Sunitinib

The two should be combined with care since Sunitinib can change the anticoagulation effect; the INR/PT should be monitored.

Bevacizumab x Sunitinib

The combination is not advisable as it can augment the danger of microangiopathic haemolytic anaemia and other poisoning.

• Drug-Food Interaction:

Food:

Due to the potential to increase the blood concentration of Sunitinib, grapefruit and grapefruit juice is not recommended to be used with Sunitinib. If this is not the case, Sunitinib can be taken either with or without food.

• Drug-Disease Interaction:

Cardiac toxicity: Sunitinib should be used under careful attention in patients who had been known to have cardiac disease before as it can decrease the left ventricular ejection fraction and predisposes such patients to cardiac failure.

Hepatic impairment: In hepatically impaired patient, with severe hepatic impairment, use of sunitinib is to be considered with caution.

Hypertension: If hypertension is newly diagnosed treatment should be very aggressive during treatment.

Contraindication of Sutenamo (Sunitinib 50mg) capsule

Sunitinib is not recommended if the patient is known to be hypersensitive to sunitinib or its excipients, pregnant or has breastfed. The patient should be administered carefully, if they have severe liver impairment, severe heart failure or uncontrolled hypertension.

Dosage of Sutenamo (Sunitinib 50mg) capsule

The dose of sunitinib is suggested to be 50mg/kg/day and put on a 4 weeks on/2 weeks off schedule in RCC and GIST

Storage of Sutenamo (Sunitinib 50mg) capsule

The Sutenamo capsules are to be kept under room temperature conditions (15-30 o C), without a lot of moisture and heat. They must never be left out of the reach of children and they must always be kept in their original package.

Missed Dose of Sutenamo (Sunitinib 50mg) capsule

When there is a missed dose, the patient must take it immediately they recall on the same day. In case it is already the following day, the dose which has been missed should be missed. Never take two doses in the same day to compensate a missed dose.

Other General Information of Sutenamo (Sunitinib 50mg) capsule

In the long term, sunitinib can result in fatigue, skin alterations or discolouration of hair. They must be adequately hydrated, eat a healthy diet and attend the follow-ups regularly. The clinician in charge should be informed of any new or abnormal symptoms so that he/she can advise and promptly attend to them.

FAQs of Sutenamo (Sunitinib 50mg) capsule

1. Why is cardiac monitoring important during Sunitinib therapy?

As the cardiac contractility and left ventricular ejection fraction may be decreased by Sunitinib, regular cardiac evaluations will help in early detection of any cardiac changes and prompt intervention.

2. Does Sutenamo have any serious lung side effects?

Sunitinib can also in certain situations lead to pulmonary complications. Patients need to report to their physician when they experience new onset cough, chest pain or breathing difficulty.

3. Does Sutenamo have any impact on blood pressure?

Yes, Sunitinib has a known side effect of hypertension. Monitoring of blood pressure should be done on a regular basis during treatment and antihypertensive drugs can be added or increased when needed.

4. What do I do when I am so fatigued or lightheaded?

The doctor should be informed of such symptoms experienced. The doctor could then re-examine and change the dosage, where necessary.

5. Am I able to carry on with normal activities?

Yes, unless fatigued or feeling very dizzy. Patients should visit their doctor in case of a severe loss of daily activities.

Fact Box of Sutenamo (Sunitinib 50mg) capsule :

References

• FDA Prescribing Information – Sunitinib
  https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021938s040lbl.pdf
•  European Medicines Agency (EMA) – Sunitinib Product Information
  https://www.ema.europa.eu/en/documents/product-information/sutent-epar-product-information_en.pdf
• DrugBank – Sunitinib
  https://go.drugbank.com/drugs/DB01268
• National Cancer Institute (NCI) – Sunitinib
  https://www.cancer.gov/about-cancer/treatment/drugs/sunitinib