Acaluxen 100 mg | Acalabrutinib INN | Worldwide Delivery

Acaluxen 100 mg (Acalabrutinib) is a second-generation Bruton tyrosine kinase inhibitor, used for the treatment of Mantle cell lymphoma, chronic lymphocytic lymphoma, and small lymphocytic lymphoma. It works by impeding the signaling path of proteins that help cancer cells grow. 

What is Acalabrutinib used for?
Acaluxen is a kinase inhibitor and, in adult patients, is used for:

• Patients with Mantle Cell Lymphoma (MCL) who have had one or more prior therapies. This indication was granted accelerated approval based on the overall response. Continued approval may be contingent on confirmatory studies establishing clinical benefit.
• Patients with Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL) have also been approved for these conditions.

How does Acalabrutinib work?

Acalabrutinib is a selective covalent inhibitor that inhibits Bruton’s tyrosine kinase (BTK) by attaching to its active site with a covalent bond. BTK is a major B-cell signaling protein responsible for their proliferation, migration, and attachment. Preclinical and clinical studies have demonstrated that by inhibiting BTK, B-cell proliferation and tumor growth are decreased.

How is Acalabrutinib administered?

• 100 mg daily by mouth until disease progression or unacceptable toxicity.
• Do not crush or chew the tablet; swallow it whole with a glass of water.
• Do not take an overdose if you miss a dose. Consult with your healthcare provider immediately.
• Take the medicine at the same time every day. 
• Monitor your health to avoid unusual side effects. 

Acalabrutinib Side Effects

Common side effects

• Neutrophils decreased/neutropenia 
• Platelets decreased/thrombocytopenia 
• Headache 
• Diarrhea 
• Musculoskeletal pain 
• Fatigue 
• Rash 
• Nausea 
• Myalgia 
• Bruising 
• ALT increased 
• Hemorrhage 
• Second primary malignancy
• AST increased 
• Lymphocytosis 
• Arthralgia 
• Abdominal pain 
• Constipation 
• Urinary tract infection 
• Bilirubin increased 
• Vomiting 
• Dizziness 

Rare side effects

• Pneumonia 
• Atrial fibrillation/flutter 
• Epistaxis 
• Creatinine increased 1.5-3x ULN 
• Herpesvirus infection 
• Hypertension 

What are the adverse reactions of Acalabrutinib 100 mg?

Hemorrhage: Since Acaluxen became available for prescription, serious and life-threatening bleeding incidents have been reported. About 2 percent of the patients experienced more serious grade 3 bleeding, and 50 percent suffered from minor bleeding incidents (bruises and petechiae). The reasons for the problems remain unknown. Patients on antiplatelet or anticoagulant regimens have a higher risk of bleeding and need special attention. For surgical patients, Acaluxen may need to be withdrawn for a period of 3 to 7 days, based on the individual bleeding risk.

Infection: Out of 612 patients with blood malignancies on monotherapy with Acaluxen in a database, syncope, atrial, or flutter episodes occurred in 3 percent of cases, with grade 3 events in 1 percent. Patients should be evaluated and treated as appropriate.

Cytopenias: There were infections and sometimes serious, opportunistic, or life-threatening cases in patients who received Acaluxen monotherapy. Aged 3 and older, 18% appeared to have some form of pneumonia. Some patients with PML have been reported with reactivated Hepatitis B. Prophylaxis would be appropriate for patients at higher risk; however, all patients should be monitored and treated immediately if any infection occurs.

Secondary Primary Malignancies: During the Acaluxen LY-004 trial, the patients suffering from hematologic malignancies were reported to have suffered from Grade 3 or 4 cytopenias, which included neutropenia in 23% of cases, thrombocytopenia in 8% of cases, and anemia in 11% of all cases. all cases. counts during the therapy were recorded and monitored every month.

Pregnancy and Lactation

• You are not allowed to conceive if you are taking this medication. It may harm the fetus in your womb.
• If you are already pregnant, consult your doctor before taking this medication.
• Use proper contraception, both the male and the female.
• Breastfeeding is not allowed while taking this medication. 
• Ask your healthcare provider how much time you should wait to start breastfeeding after taking this medication.

How to store Acalabrutinib?

Do not store this medication above 30⁰C. Keep away from light and out of the reach of children.

Frequently Asked Questions (FAQs)

Is Acaluxen 100 mg as effective as Calquence?

Yes. Acaluxenis is as effective as Calquence. Because it has the same active ingredient (Acalabrutinib) the Calquence. On the other hand, because of generic medicine, Acaluxenis is affordable and cost-friendly for every patient, whereas Calquence costs a very high price. 

Is Acalabrutinib FDA/WHO approved?

“On January 16, 2025 FDA approved acalabrutinib with bendamustine and rituximab for adults with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT)”. Source link is here. 

The FDA also granted traditional approval to acalabrutinib as a single agent for adults with previously treated MCL. Acalabrutinib  Disclaimer: accelerated approval for this indication in 2017.

How much does acalabrutinib cost?

The price of Acalabrutinib 100 mg depends on the brand, availability, and other factors. The generic brand of Acalabrutinib, such as Acaluxen, manufactured by Everest Pharmaceuticals, is lower than CALQUENCE. The estimated cost of the whole treatment depends on the required dosage, duration of the treatment, and varies from patient to patient. 

Who makes Acalabrutinib?

Acalabrutinib was discovered by AstraZeneca and marketed with the brand name CALQUENCE. It comes in capsule form at a 100 mg strength. 

How long does Acalabrutinib take to work?

Acaluxen starts working after taking the first dose, but it takes a few weeks to see the result in the imaging tests. The result from the treatment is not equal for all; in some cases, it may take a few weeks to months to see the effective results. Healthcare providers suggest that patients should continue the treatment until disease progression or expected improvement is not seen. You should take Acalabrutinib as long as the benefits come from the treatment or your doctor tells you to stop.

What herbs interfere with Acalabrutinib?

The St. John’s wort makes the drug less effective if it is administered together. Ginger may increase the blood levels and side effects. It is essential to inform your doctor about the herbs you are taking, as your doctor will check which herbs interfere with Acalabrutinib and cannot be administered together. 

What is the difference between Acalabrutinib and Ibrutinib?

Acalabrutinib is a second-generation Bruton tyrosine kinase inhibitor, offering more selective targets and similar efficacy with a more favourable safety profile with fewer heart and bleeding issues compared to Ibrutinib. While both are effective for chronic lymphocytic leukemia, Acalabrutinb has lower off effects, improving tolerability and patient outcomes for long-term treatment.

Disclaimer: Do not use this information as a medical substitute; always consult your doctor before taking any prescription medicine.