Sunisam Sunitinib Malate 50 MG (Sutent)

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Brand Name

Sunisam 50mg Capsule

Generic Name

Sunitinib (as Sunitinib Malate)

Strength

50 mg

Drug Class

Kinase Inhibitor / Multi-Targeted Receptor Tyrosine Kinase Inhibitor (RTKI)

Therapeutic Class

Anti-cancer / Targeted Therapy for Solid Tumors

Mechanism of Action

Sunitinib blocks key growth factor receptors (VEGFR-1, -2, -3, PDGFR $\alpha/\beta$, KIT, and RET). This starves the tumor by inhibiting angiogenesis (new blood vessel formation) and directly suppressing the growth and spread of cancer cells.

Indications (Uses)

Used in adults for the treatment of: Gastrointestinal Stromal Tumor (GIST) (after Imatinib failure), Advanced Renal Cell Carcinoma (RCC) (Kidney Cancer), and Progressive, well-differentiated Pancreatic Neuroendocrine Tumors (pNET).

Dosage & Administration

RCC/GIST Dose: The standard starting dose is 50 mg taken orally once daily for a 4-week treatment period, followed by a 2-week break (a 6-week cycle). pNET Dose: Typically 37.5 mg taken orally once daily continuously. Administration: Taken once daily, with or without food. Swallow capsule whole. Do not open, crush, or chew.

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Product introduction

Sunisam 50mg Capsule is a medicine used in the treatment of kidney cancer and gastrointestinal stromal tumor. It works by blocking specific enzymes that promote the growth of cancer cells. This way it shrinks the tumor and slows down its progression.

Sunisam 50mg Capsule can be taken with or without food, but try to have it at the same time every day to get the most benefits. Your doctor will decide what dose is necessary and how often you need to take it. This will depend on what you are being treated for and may change from time to time. You should take it exactly as your doctor has advised. Taking it in the wrong way or taking too much can cause very serious side effects. It may take several weeks or months for you to see or feel the benefits but do not stop taking it unless your doctor tells you to.

Common side effects of this medicine include weakness, diarrhea, nausea, vomiting, taste change, and decreased appetite. The doctor may advise for regular monitoring of blood pressure and thyroid gland function while taking this medicine. It may decrease blood sugar levels. In fact, the levels can decrease to the extent that the patient may faint. So, if you are diabetic then it is important to check your blood sugar levels regularly. Additionally, you should also consult the doctor if the dose of anti-diabetic medicines needs to be adjusted.

Before taking it, tell your doctor if you have heart disease, liver, or kidney problems or bleeding disorder. Many other medicines can affect, or be affected by, this medicine so let your healthcare team know all medications you are using. This medicine is not recommended during pregnancy or while breastfeeding. The use of effective contraception by both males and females during treatment is important to avoid pregnancy.


Uses of Sunisam Capsule

  • Kidney cancer
  • Gastrointestinal stromal tumour

Benefits of Sunisam Capsule

In Kidney cancer

Kidney cancer is a type of cancer that begins in the cells of the kidneys and can grow and spread if not treated. Sunisam 50mg Capsule works by blocking specific proteins that help cancer cells grow and multiply. This slows the progression of the disease and helps reduce tumor size, improving overall outcomes for patients with advanced kidney cancer.

Side effects of Sunisam Capsule

Most side effects do not require any medical attention and disappear as your body adjusts to the medicine. Consult your doctor if they persist or if you’re worried about them

Common side effects of Sunisam

  • Decreased appetite
  • Mucositis
  • Skin discoloration
  • Hand-foot-and-mouth disease
  • Change in color of hair
  • Decreased white blood cell count (neutrophils)
  • Decreased white blood cell count (lymphocytes)
  • Increased aspartate aminotransferase
  • Increased alanine aminotransferase
  • Increased lipase in the blood
  • Increased creatinine level in blood
  • Decreased in left ventricular ejection fraction
  • Decreased potassium level in blood
  • Increased sodium level in blood
  • Mouth pain
  • Tongue pain
  • Piles
  • Pain in extremity
  • Nasopharyngitis (inflammation of the throat and nasal passages)
  • Increased bilirubin in the blood
  • Dryness in mouth
  • Hand-foot syndrome
  • Bleeding disorder
  • Nausea
  • Vomiting
  • Abdominal pain
  • Rash
  • Weakness
  • Fatigue
  • Flatulence
  • Bleeding
  • Insomnia (difficulty in sleeping)
  • Diarrhea
  • Constipation
  • Taste change
  • Hair loss
  • Decreased level of thyroid hormones
  • High blood pressure
  • Muscle pain
  • Fever
  • Cough
  • Breathlessness
  • Back pain
  • Weight loss

How to use Sunisam Capsule

Take this medicine in the dose and duration as advised by your doctor. Sunisam 50mg Capsule may be taken with or without food, but it is better to take it at a fixed time.

How Sunisam Capsule works

Sunisam 50mg Capsule is an anti-cancer medication. It works by binding and blocking certain cell surface protein (tyrosine kinase) responsible for the propagation of cancer growth. It also restricts the growth of new blood vessels within the tumor. This is how it prevents the proliferation of malignant cancers.

Safety advice

warnings

Alcohol

CONSULT YOUR DOCTOR
It is not known whether it is safe to consume alcohol with Sunisam 50mg Capsule. Please consult your doctor.
warnings

Pregnancy

CONSULT YOUR DOCTOR
Sunisam 50mg Capsule may be unsafe to use during pregnancy. Although there are limited studies in humans, animal studies have shown harmful effects on the developing baby. Your doctor will weigh the benefits and any potential risks before prescribing it to you. Please consult your doctor.
warnings

Breast feeding

CONSULT YOUR DOCTOR
Sunisam 50mg Capsule is probably unsafe to use during breastfeeding. Limited human data suggests that the drug may pass into the breastmilk and harm the baby.
warnings

Driving

UNSAFE
Sunisam 50mg Capsule may cause side effects which could affect your ability to drive.
Sunisam 50mg Capsule may cause dizziness during the treatment. Do not drive or operate machineries if you experience this while on treatment with the medicine.
warnings

Kidney

SAFE IF PRESCRIBED
Sunisam 50mg Capsule is safe to use in patients with kidney disease. No dose adjustment of Sunisam 50mg Capsule is recommended.
warnings

Liver

SAFE IF PRESCRIBED
Sunisam 50mg Capsule is safe to use in patients with liver disease. No dose adjustment of Sunisam 50mg Capsule is recommended.

What if you forget to take Sunisam Capsule?

If you miss a dose of Sunisam 50mg Capsule, skip it and continue with your normal schedule. Do not double the dose.

Quick tips

  • Sunisam 50mg Capsule is used for the treatment of thyroid cancer.
  • Take it with or without food, preferably at the same time each day.
  • Diarrhea may occur as a side effect. Drink plenty of fluids and inform your doctor if it doesn’t stop or if you find blood in your stools.
  • Use a reliable contraceptive method to prevent pregnancy while you are taking this medicine and for a month after you stop taking it.
  • It may affect wound healing time. Be careful while shaving, cutting fingernails or toenails, or using sharp objects.
  • Monitor your blood pressure regularly while taking this medication. Inform your doctor if you notice symptoms of very high blood pressure such as severe headache, confusion, problems with your eyesight, nausea or vomiting.
  • Monitoring of thyroid gland function is required while taking this medicine.  Inform your doctor if you notice symptoms of weight gain, dry skin, and hair.
  • It may cause serious bleeding problem. Inform your doctor if you get headaches, stomach pain or if you notice blood in your urine or stools.
  • Inform your doctor about the consumption of Sunisam 50mg Capsule before going for surgical procedure.
  • Do not take this medicine if you are pregnant, planning to conceive or breastfeeding.

FAQs

How should I take Sunisam 50mg Capsule?

You should take Sunisam 50mg Capsule exactly as directed by your doctor. It should be started by doctors who have experience in administering cancer medicines. Take it once a day with or without food. Do not drink grapefruit juice or eat grapefruit during your treatment with Sunisam 50mg Capsule, as the chances of side effects may be more.

Does Sunisam 50mg Capsule have any effect on skin and hair?

During treatment with Sunisam 50mg Capsule, your skin may get lighter and there may be hair loss. Also, patient may experience dryness, thickness or cracking of the skin, blisters, or rashes on the palms and soles. But, these side effects are reversible and go away once the medicine is stopped. Sunisam 50mg Capsule may also cause serious skin reactions such as severe rash or rapidly spreading skin ulceration which could be fatal. Therefore, inform your doctor immediately if symptoms of infection occur around a skin injury. Let your doctor know if you have fever, pain, redness, swelling, or drainage of pus or blood.

What is the most important thing I need to know about Sunisam 50mg Capsule?

Sunisam 50mg Capsule can cause serious side effects such as severe liver problems that can lead to death. Therefore, tell your doctor right away if you experience itching, yellow eyes or skin, dark urine or pain or discomfort in the right upper stomach area. Your doctor will get blood tests done to check your liver function before and during treatment with Sunisam 50mg Capsule. In case you develop liver problems, your doctor may stop the medicine temporarily or permanently.

Are generics available for Sunisam 50mg Capsule? How does Sunisam 50mg Capsule work?

There are no generics available for Sunisam 50mg Capsule. Sunisam 50mg Capsule blocks an enzyme which promotes the growth and spread of cancer cells. This enzyme is called protein kinase and is present on the surface of cancer cells. Blocking this enzyme stops the spread of cancer. Examples of other protein kinase inhibitors are erlotinib, gefitinib, lapatinib, vemurafenib and dasatinib.

Can Sunisam 50mg Capsule be used in combination with other chemotherapy medicines?

There are no studies that support the use of Sunisam 50mg Capsule with other chemotherapy medicines. For example, Sunisam 50mg Capsule is used in Gastrointestinal stromal tumour (GIST), a type of cancer of the stomach and bowel, when imatinib (another anticancer medicine) no longer works or the patient cannot take imatinib.

Does Sunisam 50mg Capsule have any effect on blood sugar levels in diabetics?

Yes, Sunisam 50mg Capsule may decrease your blood sugar levels. Therefore, if you are a diabetic, you need to be extra careful since your blood sugar levels may become so low that you may become unconscious. Keep a regular check on the blood sugar levels, based on which your dose of anti-diabetics may be changed.

Can Sunisam 50mg Capsule cause any change in blood pressure?

Generally, Sunisam 50mg Capsule is known to cause an increase in blood pressure. Therefore, it is important that you keep a regular check on your blood pressure levels. Inform your doctor if you have severe headache, dizziness, lightheadedness or change in vision. Your doctor may prescribe a medicine to treat the increase blood pressure or may stop your treatment temporarily till your blood pressure returns to normal.

How should I take Sunisam 50mg Capsule?

You should take Sunisam 50mg Capsule exactly as directed by your doctor. It should be started by doctors who have experience in administering cancer medicines. Take it once a day with or without food. Do not drink grapefruit juice or eat grapefruit during your treatment with Sunisam 50mg Capsule, as the chances of side effects may be more.

Does Sunisam 50mg Capsule have any effect on skin and hair?

During treatment with Sunisam 50mg Capsule, your skin may get lighter and there may be hair loss. Also, patient may experience dryness, thickness or cracking of the skin, blisters, or rashes on the palms and soles. But, these side effects are reversible and go away once the medicine is stopped. Sunisam 50mg Capsule may also cause serious skin reactions such as severe rash or rapidly spreading skin ulceration which could be fatal. Therefore, inform your doctor immediately if symptoms of infection occur around a skin injury. Let your doctor know if you have fever, pain, redness, swelling, or drainage of pus or blood.

What is the most important thing I need to know about Sunisam 50mg Capsule?

Sunisam 50mg Capsule can cause serious side effects such as severe liver problems that can lead to death. Therefore, tell your doctor right away if you experience itching, yellow eyes or skin, dark urine or pain or discomfort in the right upper stomach area. Your doctor will get blood tests done to check your liver function before and during treatment with Sunisam 50mg Capsule. In case you develop liver problems, your doctor may stop the medicine temporarily or permanently.

Can Sunisam 50mg Capsule be used in combination with other chemotherapy medicines?

There are no studies that support the use of Sunisam 50mg Capsule with other chemotherapy medicines. For example, Sunisam 50mg Capsule is used in Gastrointestinal stromal tumour (GIST), a type of cancer of the stomach and bowel, when imatinib (another anticancer medicine) no longer works or the patient cannot take imatinib.

Does Sunisam 50mg Capsule have any effect on blood sugar levels in diabetics?

Yes, Sunisam 50mg Capsule may decrease your blood sugar levels. Therefore, if you are a diabetic, you need to be extra careful since your blood sugar levels may become so low that you may become unconscious. Keep a regular check on the blood sugar levels, based on which your dose of anti-diabetics may be changed.

Can Sunisam 50mg Capsule cause any change in blood pressure?

Generally, Sunisam 50mg Capsule is known to cause an increase in blood pressure. Therefore, it is important that you keep a regular check on your blood pressure levels. Inform your doctor if you have severe headache, dizziness, lightheadedness or change in vision. Your doctor may prescribe a medicine to treat the increase blood pressure or may stop your treatment temporarily till your blood pressure returns to normal.

Are generics available for Sunisam 50mg Capsule? How does Sunisam 50mg Capsule work?

There are no generics available for Sunisam 50mg Capsule. Sunisam 50mg Capsule blocks an enzyme which promotes the growth and spread of cancer cells. This enzyme is called protein kinase and is present on the surface of cancer cells. Blocking this enzyme stops the spread of cancer. Examples of other protein kinase inhibitors are erlotinib, gefitinib, lapatinib, vemurafenib and dasatinib.

References:-

  • U.S. Food and Drug Administration (FDA) – Drug Label (Sutent/Sunitinib):
    • https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021938s13s17s18lbl.pdf
    • (The FDA label confirming the 50mg dose and the 4-weeks-on/2-weeks-off (4/2) schedule as the recommended dosage for GIST and advanced RCC.)
  • Philippines Food and Drug Administration (FDA) – Drug Registration (Example):
    • https://verification.fda.gov.ph/ALL_DrugProductsview.php?showdetail=&registration_number=DRP-16439
    • (Registration entry for Sunib 50mg Capsule (Sunitinib) in the Philippines FDA portal, confirming local approval and generic name.)
  • NIH – PubMed Central (PMC) – Pivotal Trial Efficacy (GIST):
  • eviQ (Australian Cancer Guidelines) – Dosing Protocol:
  • NIH – PubMed Central (PMC) – Review on Management of Side Effects:
Brand Name

Sunisam 50mg Capsule

Generic Name

Sunitinib (as Sunitinib Malate)

Strength

50 mg

Drug Class

Kinase Inhibitor / Multi-Targeted Receptor Tyrosine Kinase Inhibitor (RTKI)

Therapeutic Class

Anti-cancer / Targeted Therapy for Solid Tumors

Mechanism of Action

Sunitinib blocks key growth factor receptors (VEGFR-1, -2, -3, PDGFR $\alpha/\beta$, KIT, and RET). This starves the tumor by inhibiting angiogenesis (new blood vessel formation) and directly suppressing the growth and spread of cancer cells.

Indications (Uses)

Used in adults for the treatment of: Gastrointestinal Stromal Tumor (GIST) (after Imatinib failure), Advanced Renal Cell Carcinoma (RCC) (Kidney Cancer), and Progressive, well-differentiated Pancreatic Neuroendocrine Tumors (pNET).

Dosage & Administration

RCC/GIST Dose: The standard starting dose is 50 mg taken orally once daily for a 4-week treatment period, followed by a 2-week break (a 6-week cycle). pNET Dose: Typically 37.5 mg taken orally once daily continuously. Administration: Taken once daily, with or without food. Swallow capsule whole. Do not open, crush, or chew.

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Sunisam 50mg Sunitinib capsules for kidney cancer, GIST, and pancreatic neuroendocrine tumors. Sunisam Sunitinib Malate 50 MG...

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