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About ALPELISIB

ALPELISIB belongs to a class of kinase inhibitors. It is used in conjunction with fulvestrant to treat postmenopausal women and men with hormone receptor (HR)-positive, HER2-negative, PIK3CA-mutated, advanced, or metastatic breast cancer.

ALPELISIB contains Alpelisib. In breast cancers with a PIK3CA gene mutation, a protein called PI3K is involved in helping the cancer cells multiply and grow. By blocking the action of PI3K, Alpelisib helps stop the growth and spread of the cancer.

To treat your condition effectually, continue using ALPELISIB for as long as your doctor has prescribed it. The most common side effects include rash, decreased appetite, weight loss, nausea, mouth sores, hair loss, tiredness and weakness, vomiting, changes in certain blood tests, allergic reactions, skin reactions, high blood sugar levels, lung problems, and diarrhea. You should talk to your doctor if you persistently experience these side effects.

Avoid taking ALPELISIB if you are allergic to it. It is not recommended for use in pregnancy. Lactating women do not breastfeed during treatment with ALPELISIB and for one week after the last dose. Alcohol should be avoided during treatment with this medicine. Safety and effectiveness in children have not been established.

Uses of ALPELISIB

Advanced or metastatic breast cancer

Medicinal Benefits

ALPELISIB contains Alpelisib, which belongs to a class of kinase inhibitors. It is used in conjunction with fulvestrant to treat postmenopausal women and men with hormone receptor (HR)-positive, HER2-negative, PIK3CA-mutated, advanced, or metastatic breast cancer. In breast cancers with a PIK3CA gene mutation, a protein called PI3K is involved in helping the cancer cells multiply and grow. By blocking the action of PI3K, Alpelisib helps stop the growth and spread of the cancer.

Directions for Use

ALPELISIB should be swallowed as a whole with a glass of water. Do not crush, chew, or break the tablets. The doctor determines the dose and duration based on your health condition.

Storage

Store in a cool and dry place away from sunlight

Side Effects of ALPELISIB

  • Rash
  • Decreased appetite
  • Weight loss
  • Nausea
  • Mouth sores
  • Hair loss
  • Tiredness and weakness
  • Vomiting
  • Changes in certain blood tests
  • Severe allergic reactions
  • High blood sugar levels
  • Lung problems
  • Diarrhea

In-Depth Precautions and Warning

Drug Warnings

It is not advised during pregnancy, nursing, or for children or young adults under 18. Before taking the ALPELISIB, inform your doctor about all your medical conditions (especially lung infections, diarrhoea, diabetics, kidney or liver impairment), sensitivities or allergic conditions, and all medications you use. Consult your doctor right away if you become pregnant while taking ALPELISIB. Exposure of an unborn child to this medication could cause congenital disabilities, so you should not become pregnant or father a child while on this medication. Effective birth control is required throughout treatment and at least one week after treatment. You should not breastfeed while taking this medication for two weeks after your last dose.

Drug Interactions

Drug-Drug Interactions: ALPELISIB may interact with anticancer medications (e.g. Apalutamide), anticonvulsant medication (e.g. carbamazepine), anticoagulant medication (e.g. edoxaban), antiepileptic medications (e.g. primidone).

Drug-Food Interactions: Avoid the consumption of alcoholic beverages.

Drug-Disease Interactions: ALPELISIB interacts with disease conditions, including cutaneous manifestations (skin inflammation), diabetes, diarrhoea, osteonecrosis of the jaw (a condition where the jawbone is exposed and not covered by gums), pneumonitis (inflammation in your lung tissues) and renal impairment.

Drug-Drug Interactions Checker List:

  • APALUTAMIDE
  • CARBAMAZEPINE
  • EDOXABAN
  • PRIMIDONE
  • Safety Advice

    • Safety Warning

      Alcohol

      caution

      Avoid alcohol consumption while on treatment with ALPELISIB.

    • Safety Warning

      Pregnancy

      unsafe

      ALPELISIB should not be used during pregnancy. So, inform your doctor if you are pregnant or suspect pregnancy. You or your partner must use a reliable form of contraception to prevent pregnancy while taking these medications.

    • Safety Warning

      Breast Feeding

      caution

      Lactating women should not breastfeed throughout ALPELISIB treatment and for one week following the final dosage.

    • Safety Warning

      Driving

      caution

      ALPELISIB does not influence the ability to drive or use machines. However, go only if you are alert, as the ALPELISIB may cause weakness or tiredness in some people.

    • Safety Warning

      Liver

      caution

      Limited information is available. Inform your doctor before taking the ALPELISIB if you have had a liver impairment/disorder history. Your doctor will prescribe only if the benefits outweigh the risks.

    • Safety Warning

      Kidney

      caution

      No dose adjustment is recommended for patients with mild to moderate renal impairment (CLcr 30 to < 90 mL/min). The effect of severe renal impairment (CLcr < 30 mL/min) on alpelisib is unknown. So, inform your doctor before taking the ALPELISIB if you have had a kidney impairment/disorder history. Your doctor will prescribe only if the benefits outweigh the risks.

    • Safety Warning

      Children

      unsafe

      Safety and effectiveness in patients below the age of 18 years have not been established. Hence, use is not recommended.

    Habit Forming

    No

    Diet & Lifestyle Advise

    • After your treatment begins, several dietary adjustments can help you control side effects.
    • Anyone suffering from a chronic illness, including cancer, should consume foods high in protein, healthy fats, whole grains, and vitamins and minerals.
    • Plant-based proteins are among the greatest meals during chemotherapy or other cancer treatments. They have the highest concentrations of vitamins and minerals, such as nuts, seeds, beans and legumes.
    • Eat a healthy diet and exercise regularly to maintain proper weight.
    • Include leafy vegetables, citrus fruits, fatty fish, berries, yoghurt, apples, peaches, cauliflower, cabbage, broccoli, beans, and herbs.
    • De-stress yourself by meditating, reading books, taking a warm bubble bath or listening to soothing music.
    • Performing yoga may also help in improving both physical and mental health.
    • Maintain a healthy weight by performing regular low-strain exercises and eating healthy food.
    • Get optimal sleep; rest well.
    • Avoid smoking and alcohol consumption.
    • Avoid fast food, fried food, processed meats, refined carbs and added sugars.

    Special Advise

    • Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to ALPELISIB.
    • Pregnancy testing is recommended prior to starting treatment with ALPELISIB.
    • Do not donate Sperm throughout treatment and at least one week after treatment.

    Patients Concern

    Disease/Condition Glossary

    Breast cancer: Breast cancer is a type of cancer that develops in breast cells stimulated by a female sex hormone called estrogen. Breast cancer may form in lobules (glands that produce milk), ducts of the breast (the pathway that brings milk from glands to the nipple), and the fatty tissue or the fibrous connective tissue within the breast. The tumour cells invade other healthy breast cells and travel to lymph nodes, a primary pathway for the cancer cells to move to other body parts. Symptoms of breast cancer include a lump in the breast or tissue thickening, which feels different than the normal surrounding tissues, breast pain, redness, swelling, and nipple discharge other than breast milk.

    Metastatic breast cancer, also called stage IV breast cancer, has spread to another part of the body, most commonly the bones, lungs, brain, or liver. The process of cancer spreading is called metastasis. Metastasis happens when cancer cells break away from the original tumour in the breast and travel to other parts of the body. These cancer cells travel through the bloodstream or the lymphatic system.

    FAQs

    How does ALPELISIB works?

    ALPELISIB contains Alpelisib. In breast cancers with a PIK3CA gene mutation, a protein called PI3K is involved in helping the cancer cells multiply and grow. By blocking the action of PI3K, Alpelisib helps stop the growth and spread of the cancer.

    Does ALPELISIB cause a change in sugar levels?

    Hyperglycemia is common with ALPELISIB and can be severe. Your healthcare provider will monitor your blood sugar levels before you start and during treatment with ALPELISIB. Your healthcare provider may monitor your blood sugar levels more often if you have a history of Type 2 diabetes. Tell your healthcare provider right away if you develop symptoms of hyperglycemia, including excessive thirst, dry mouth, more frequent urination than usual or a higher amount of urine than normal and increased appetite with weight loss.

    Is ALPELISIB a traditional chemotherapy drug?

    It is critical to understand that Alpelisib is not a traditional chemotherapy drug and functions in a different manner. It works by specifically targeting cancer cells and preventing their growth and spread.

    What important things should I take care of while taking ALPELISIB?

    While taking ALPELISIB, make sure you visit your doctor at all the appointments to ensure that treatment works. Regular monitoring of blood and lipid tests and weight checks are required. An effective way of contraception should be used by both men and women while taking the ALPELISIB.

    Is Alpelisib a cause of infertility?

    Based on findings from animal studies, ALPELISIB may impair fertility in males and females of reproductive potential. Discuss the risks of taking this medication with your doctor.

    Available Medicines for

    ALPELISIB