BIGBEAR
PHARMACEUTICAL
Alpelisib is an oral phosphatidylinositol-3-kinase (PI3K) inhibitor. Its mechanism of action is to block the activity of PI3K enzymes, inhibit the proliferation and spread of tumor cells, and simultaneously induce the apoptosis of breast cancer cells.
AuthenticGuaranteeFast DeliveryPrivacy Alpelisib is administered as an oral tablet taken whole with meals at a fixed time each day. During treatment, close monitoring of blood glucose levels is required, and hyperglycemia is its main adverse reaction.
This medicinal product is indicated in combination with fulvestrant for the treatment of postmenopausal women and men with advanced hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer.
It is intended for patients whose disease has progressed on or after prior endocrine therapy and whose tumors harbor a PIK3CA gene mutation. Treatment should only be initiated upon confirmation of a PIK3CA gene mutation using a blood sample and/or tumor tissue specimen.
For oral use. Take at a fixed time each day with food. Swallow tablets whole. Do not chew, crush, or split tablets. Do not use damaged tablets. If vomiting occurs after taking the dose, do not take an additional dose that day.
The recommended starting dose is 300mg (two 150mg tablets) taken once daily. Dose adjustments based on patient tolerability: 250mg (one 200mg tablet + one 50mg tablet) or 200 mg (one 200mg tablet).
If a dose is missed by less than 9 hours, take the missed dose with food as soon as possible. If a dose is missed by more than 9 hours, skip the missed dose and take the next dose at the regularly scheduled time the next day. Do not take double doses to compensate for a missed dose.
Accidental overdose may result in adverse reactions such as hyperglycemia, nausea, fatigue, and rash. Seek immediate medical attention.
Continue treatment as prescribed by the physician. The physician will regularly assess the patient's condition to determine whether to continue therapy. Patients should not discontinue treatment on their own.
No relevant data are available in patients < 18 years of age. This medicinal product is contraindicated in this population.
Contraindicated. This medicinal product may cause fetal harm. Females of reproductive potential must have pregnancy excluded prior to initiating treatment. Effective contraception must be used during treatment and for at least 1 week after the last dose. Suspected pregnancy requires immediate medical attention.
Contraindicated. It is unknown whether this medicinal product is excreted in human milk. Breastfeeding must be discontinued during treatment and for at least 1 week after the last dose.
Male patients must use condoms during sexual intercourse with females of reproductive potential during treatment and for at least 1 week after the last dose. If the partner becomes pregnant or is suspected to be pregnant, immediate medical attention is required.
This medicinal product may cause adverse reactions of varying severity grades. Severe adverse reactions require immediate discontinuation of treatment and medical attention. Some adverse reactions are associated with laboratory abnormalities, as detailed below:
Symptoms related to hyperglycemia (excessive thirst, increased urination, increased appetite with weight loss); symptoms related to lymphopenia (fever, cough, lymphadenopathy, etc.);
Urinary tract infection, anemia, thrombocytopenia, decreased appetite, headache, dysgeusia, diarrhea, nausea, vomiting, stomatitis, rash, alopecia, pruritus/dry skin, fatigue, peripheral edema, pyrexia, weight loss, hypocalcemia, hypokalemia, hypertension, etc.;
Laboratory abnormalities: Elevations in enzymes such as gamma-glutamyltransferase, alanine aminotransferase; hyperglycemia; increased serum creatinine/calcium; decreased levels of blood cells such as lymphocytes, platelets.
Severe allergic reactions, ketoacidosis, pneumonia, acute kidney injury, osteonecrosis of the jaw, erythema multiforme;
Dehydration, insomnia, dry eye, vision blurred, lymphedema, toothache, gingivitis, palmar-plantar erythrodysesthesia syndrome, muscle spasms/pain, generalized edema, etc.;
Laboratory abnormalities: Increased glycosylated hemoglobin.
Uncommon (incidence 0.1%-1%): Pancreatitis, Stevens-Johnson syndrome (SJS).
Unknown (incidence cannot be estimated): Colitis, hyperosmolar hyperglycemic nonketotic syndrome, angioedema, drug reaction with eosinophilia and systemic symptoms (DRESS), intraocular inflammation.
Hypersensitivity to alpelisib or to any of the excipients. This medicinal product is contraindicated in such patients.
Patients with a history of hyperglycemia/diabetes mellitus, previous occurrence of Stevens-Johnson syndrome/erythema multiforme/DRESS/toxic epidermal necrolysis (TEN), or severe jaw disease (osteonecrosis) should inform their physician prior to treatment.
Blood glucose levels must be monitored prior to treatment initiation and periodically during treatment. More frequent monitoring is recommended during the first 4 weeks (especially the first 2 weeks), and at least monthly thereafter. In case of blood glucose abnormalities, the physician may prescribe antihyperglycemic agents, temporarily withhold/reduce the dose of this medicinal product, or permanently discontinue treatment.
Patients must immediately inform their physician if severe allergic reactions, pneumonia, complications of hyperglycemia, severe skin reactions, osteonecrosis of the jaw, severe diarrhea/colitis, or other symptoms occur during treatment. The physician will provide symptomatic treatment, adjust the dose, or permanently discontinue the product as appropriate.
Patients must inform their physician prior to concomitant use of medications such as eltrombopag, lapatinib, everolimus, pantoprazole, midazolam, rifampin, carbamazepine, St. John's wort, encorafenib, warfarin, etc., to avoid drug interactions.
This medicinal product may cause fatigue and blurred vision. Caution is required when performing such activities during treatment.
Contains less than 1 mmol sodium (23mg) per tablet, i.e., essentially sodium-free.
If any issues arise, please contact us immediately.
Email:laosbigbear@gmail.com
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.
Other drugs may affect alpelisib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Take the medicine (with food) as soon as you can, but skip the missed dose if you are more than 9 hours late for the dose. Do not use two doses at one time.Call your doctor for instructions if you miss an appointment for your fulvestrant injection.
Alpelisib (Piqray brand) is used to treat types of breast cancer in men and postmenopausal women, and Vijoice brand of alpelisib is used to treat a condition called PROS (PIK3CA-Related Overgrowth Spectrum) in certain patients.
Alpelisib is a targeted therapy from a class of medicines called PI3K inhibitors (phosphoinositide 3-kinase inhibitors) and is sometimes called a kinase inhibitor. Alpelisib is only used for PIK3CA-mutated tumors as detected by an FDA-approved test.
Copyright2024@ BIGBEAR All right reserved Bigbear | Bigbear Pharmaceutical | Bigbear Laos
