Calquence (Acalabrutinib)

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  • Product Details

    Description

    Calquence blocks the action of certain enzymes in the body, which can interfere with the growth and spread of cancer cells. Calquence is used to treat mantle cell lymphoma (a type of non-Hodgkin lymphoma) in adults. This medicine is given after other treatments have failed. Calquence was approved by the US Food and Drug Administration (FDA) on an accelerated basis. In clinical studies, patients responded to this medicine. However, further studies are needed. Calquence is also used to treat chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adults.

    Directions

    How should I take Calquence? Take Calquence exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended. Calquence is usually taken once every 12 hours until your body no longer responds to the medicine. Take this medicine with a full glass of water. You may take this medicine with or without food. Calquence is available in capsule and tablet dosage forms. Use only the dosage form you have been prescribed. They cannot be interchanged. Do not chew, break, or open the Calquence capsule. Swallow the capsule whole with a glass of water.. Do not chew, crush, dissolve, or cut the Calquence tablet. Swallow the tablet whole with a glass of water. If you need surgery, tell the surgeon ahead of time that you are using acalabrutinib. You may need to stop using the medicine for a short time. While using Calquence, you may need frequent blood tests. Store at room temperature away from moisture and heat. Dosing information: Usual Adult Dose for Mantle Cell Lymphoma: 100 mg orally approximately every 12 hours Duration of Therapy: Until disease progression or unacceptable toxicity Use: Treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Usual Adult Dose for Leukemia : Monotherapy: 100 mg orally every 12 hours Duration of Therapy: Until disease progression or unacceptable toxicity In Combination With Obinutuzumab: 100 mg orally every 12 hours Duration of Therapy: Until disease progression or unacceptable toxicity. Start this drug at Cycle 1 (each cycle is 28 days); start obinutuzumab at Cycle 2 for a total of 6 cycles and refer to the obinutuzumab prescribing information for recommended dosing; administer this drug prior to obinutuzumab when given on the same day

    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.

    Cautions

    You should not use Calquence if you are allergic to acalabrutinib. To make sure this medicine is safe for you, tell your doctor if you have ever had: an active or chronic infection; a heart rhythm disorder; bleeding problems; or hepatitis B (acalabrutinib can cause this condition to come back or get worse). Taking Calquence may increase your risk of developing other types of cancer, such as skin cancer. Talk to your doctor about this risk and what skin symptoms to watch for. It is not known whether acalabrutinib will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether acalabrutinib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using Calquence, and for at least 2 weeks after your last dose.

    Side Effects

    Get emergency medical help if you have signs of an allergic reaction to Calquence: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have: unusual bleeding (nose, mouth, vagina, or rectum), or any bleeding that will not stop; signs of bleeding inside your body - dizziness, weakness, confusion, problems with speech, prolonged headache, black or bloody stools, pink or brown urine, or coughing up blood or vomit that looks like coffee grounds; heart rhythm problems - chest pain, shortness of breath, pounding heartbeats or fluttering in your chest, feeling light-headed; low red blood cells (anemia) - pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; signs of infection - fever, chills, tiredness, flu-like symptoms, cough with mucus, chest pain, trouble breathing; or signs of a serious brain infection - any change in your mental state, decreased vision, weakness on one side of your body, or problems with walking (may start gradually and get worse quickly). Your cancer treatments may be delayed or permanently discontinued if you have certain side effects. Common Calquence side effects may include: bruising; headache; muscle and joint pain; upper respiratory tract infection; diarrhea; or feeling tired. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Product Code : 13710

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