Approved by CDSCO on 23.10.2019
Acalabrutinib Capsules, for Oral Use with the trade name CALQUENCE®
Acalabrutinib is a white to yellow powder with pH-dependent solubility. It is freely soluble in water at pH values below 3 and practically insoluble at pH values above 6.
Acalabrutinib is an inhibitor of Bruton tyrosine kinase (BTK). which can interfere with the growth and spread of cancer cells. Acalabrutinib and its active metabolite, ACP-5862, form a covalent bond with a cysteine residue in the BTK active site, leading to inhibition of BTK enzymatic activity. So it is used to treat mantle cell lymphoma (a type of non-Hodgkin lymphoma) in adults. It is given after other treatments have failed. It is a prescription medicine used to treat adults with MCL, who have received at least one prior treatment for their cancer.
Dose:
The recommended dose of CALQUENCE is 100 mg taken orally approximately every twelve hours until disease progression or unacceptable toxicity. It may be taken with or without food. Store at 20°C-25°C.
Ingredients:
CALQUENCE capsules for oral administration contains 100 mg acalabrutinib and the following inactive ingredients: silicified microcrystalline cellulose, partially pregelatinized starch, magnesium stearate, and sodium starch glycolate. The capsule shell contains gelatine, titanium dioxide, yellow iron oxide, FD&C Blue 2 and is imprinted with edible black ink.
The following adverse reactions are reported:
- Bleeding problems (hemorrhage) may happen during treatment , including: blood in your stools or black stools (looks like tar)
- pink or brown urine
- unexpected bleeding, or bleeding that is severe or
- vomit blood or vomit that looks like coffee grounds
- cough up blood or blood clots
- dizziness
- weakness
- confusion
- changes in speech
- headache that lasts a long time
- Infections which happen during treatment can be serious and may lead to death. It starts with fever, chills, or flu-like symptoms.
- Decrease in blood cell counts. Decreased blood counts (white blood cells, platelets, and red blood cells) are common. So, conduct monthly blood tests to check blood counts.
- Second primary cancers. New cancers have happened in people during including cancers of the skin. Use sun protection to avoid sunlight. Heart rhythm problems (atrial fibrillation and atrial flutter) have happened in some people, like, heartbeat is fast or irregular, feel lightheaded or dizzy.
- pass out (faint)
- shortness of breath
- chest discomfort.
- The most common adverse reactions were anaemia, thrombocytopenia, headache, neutropenia, diarrhoea, fatigue, myalgia, and bruising.
Advise women not to breastfeed during treatment with CALQUENCE and for at least 2 weeks after the final dose.
