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.
Advanced or metastatic breast cancer
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.
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-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.
Avoid alcohol consumption while on treatment with ALPELISIB.
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.
Lactating women should not breastfeed throughout ALPELISIB treatment and for one week following the final dosage.
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.
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.
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 and effectiveness in patients below the age of 18 years have not been established. Hence, use is not recommended.
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.