Acalabrutinib

Acalabrutinib is a prescription medication used for the treatment of mantle cell lymphoma and chronic lymphocytic leukemia.

• Acalabrutinib is available under the following different brand names: Calquence

Adult dosage

Capsule

• 100mg

Mantle Cell Lymphoma

Adult dosage

• 100 mg orally every 12 hours

Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Adult dosage

Monotherapy

1. 100 mg orally every 12 hours
2. Combination with obinutuzumab

Cycle 1

• Days 1-28: Acalabrutinib 100 mg orally every 12 hours

Cycle 2

• Days 1-28: Acalabrutinib 100 mg orally every 12 hours
• Day 1: Obinutuzumab 100 mg IV infusion
• Day 2: Obinutuzumab 900 mg IV infusion
• Days 8 and 15: Obinutuzumab 1000 mg IV infusion

Cycles 3-7

• Day 1-28: Acalabrutinib 100 mg orally every 12 hours
• Day 1: Obinutuzumab 1000 mg IV infusion

Cycle 8 and subsequent cycles

• Day 1-28: Acalabrutinib 100 mg orally every 12 hours

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Acalabrutinib include:

• bruising,
• headache,
• diarrhea,
• tiredness, and
• muscle pain.

Serious side effects of Acalabrutinib include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• unusual bleeding (nose, mouth, vagina, or rectum),
• any bleeding that will not stop,
• dizziness,
• weakness,
• confusion,
• problems with speech,
• prolonged headache,
• black or bloody stools,
• pink or brown urine,
• coughing up blood,
• vomit that looks like coffee grounds,
• chest pain,
• shortness of breath,
• pounding heartbeats,
• fluttering in the chest,
• lightheadedness,
• pale skin,
• unusual tiredness,
• cold hands and feet,
• fever,
• chills,
• tiredness,
• flu-like symptoms,
• cough with mucus,
• chest pain,
• changes in mental state,
• decreased vision,
• weakness on one side of the body, and
• problems walking (gradual start and worsening quickly).

Rare side effects of Acalabrutinib include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Acalabrutinib has severe interactions with no other drugs.
• Acalabrutinib has serious interactions with at least 60 other drugs.
• Acalabrutinib has moderate interactions with at least 173 other drugs.
• Acalabrutinib has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Acalabrutinib?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Acalabrutinib?”

Cautions

• Serious hemorrhagic events, including fatal events, are reported; the mechanism for the bleeding events is not well understood; acalabrutinib may further increase hemorrhage risk in patients receiving antiplatelet or anticoagulant therapies, and patients should be monitored for signs of bleeding; consider the benefit-risk of withholding acalabrutinib for 3-7 days presurgery and postsurgery depending on the type of surgery and the risk of bleeding
• Serious infections (bacterial, viral, or fungal), including fatal events and opportunistic infections, are reported; monitor for infection and consider prophylaxis in patients who are at increased risk for opportunistic infections
• Cytopenias reported, including neutropenia, anemia, lymphopenia, and thrombocytopenia; monitor complete blood cell counts monthly during treatment; interrupt treatment, reduce dose, or discontinue treatment as warranted
• Second primary malignancies, including nonskin carcinomas, have occurred in patients with hematologic malignancies treated with acalabrutinib; the most frequent was skin cancer; advise patients regarding the need for protection from sun exposure
• Atrial fibrillation and flutter occurred (rare) during clinical trials; monitor for symptoms of arrhythmia (eg, palpitations, dizziness, syncope, dyspnea) and manage as appropriate
• Drug interaction overview
  • Coadministration with CYP3A inhibitors or inducers
    • Acalabrutinib is predominantly metabolized by CYP3A enzymes
    • CYP3A inhibitors are expected to increase acalabrutinib systemic exposure
    • CYP3A inducers are expected to decrease acalabrutinib systemic exposure
• See Dosage Modifications
  • Coadministration with gastric acid-reducing agents
  • Coadministration with PPIs, H2-antagonists, or antacids may decrease acalabrutinib plasma concentrations
  • See Dosage Modifications

Pregnancy and Lactation

• Based on findings in animals, may cause fetal harm when administered to pregnant women
• There are no available data on pregnant women to inform the drug-associated risk
• Pregnancy testing is recommended for females of reproductive potential before initiating therapy
• Contraception
  • Embryofetal harm and dystocia may occur when administered to pregnant women
  • Females of reproductive potential: Use effective contraception during treatment and for at least 1 week following the last dose; if used during pregnancy, or if the patient becomes pregnant while taking a drug, inform the patient of the potential hazard to a fetus
• Lactation
  • No data are available regarding the presence of acalabrutinib or its active metabolite in human milk, its effects on the breastfed child, or on milk production
  • Acalabrutinib and its active metabolite were present in the milk of lactating rats
  • Owing to the potential for adverse reactions in a breastfed child, advise lactating women not to breastfeed while taking acalabrutinib and for at least 2 weeks after the final dose