Zucarfil- Carfilzomib Inj 60 mg
Carfilzomib
Strength: 60mg
Pack Size: 1 vial
Drug Class: proteasome inhibitors
Dosage and Administration:
Carfilzomib is administered as an infusion into a vein. The infusion may last up to 30 minutes. Carfilzomib is given 2 days in a row each week, for 3 weeks, followed by one week without treatment. Each 28-day period is one treatment cycle. This means that Carfilzomib will be given on days 1, 2, 8,
9, 15. and 16 of each 28-day cycle. The doses on days 8 and 9 of each cycle will not be given from cycle 13 onwards if treated with Carfilzomib in combination with lenalidomide and dexamethasone.
Most patients will receive treatment for as long as their disease improves or remains stable. However, Carfilzomib treatment may also be stopped if experiences side effects that cannot be managed. Together with Carfilzomib also be given either lenalidomide and dexamethasone, daratumumab and dexamethasone or only dexamethasone
Cold Storage: yes
Carfilzomib is an antineoplastic agent (cancer medicine). It interferes with the growth of cancer cells, which are eventually destroyed by the body. This medicine is to be given only by or under the supervision of your doctor. This product is available in the following dosage forms: Powder for Solution.
Carfilzomib in combination with daratumumab and dexamethasone, with lenalidomide and dexamethasone, or with dexamethasone alone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
Carfilzomib (Carf) is a second-generation proteasome inhibitor approved for patients with relapsed and/or refractory multiple myeloma (RRMM) who failed prior lines of therapy. We performed a systematic review of Carf literature with meta-analysis to determine the efficacy and safety in RRMM patients.
As lenalidomide may
be used in combination with Carfilzomib, particular attention to the lenalidomide pregnancy testing and prevention requirements is needed. New or worsening cardiac failure (e.g. congestive cardiac failure, pulmonary oedema, decreased ejection fraction), myocardial ischaemia and infarction have occurred following the administration of Carfilzomib
Candiac disorders
Death due to cardiac arrest has occurred within a day of Carfilzomib administration and fatal outcomes have been reported with cardiac failure and myocardial infarction. For potential dose-related effects. While adequate hydration is required prior to dosing in cycle 1, all patients should be monitored for
evidence of volume overload, especially patients at risk for cardiac failure. The total volume of fluids may
be adjusted as clinically indicated in patients with baseline cardiac failure or who are at risk for cardiac
failure.
Stop Carfilzomib for grade 3 or 4 cardiac events until recovery and consider whether to restart Carfilzomib at 1 dose level reduction based on a benefit/risk assessment. The risk of cardiac failure is increased in elderly patients (≥75 years). The risk of cardiac failure is also increased in Asian patients.
A thorough assessment for cardiovascular risk factors prior to starting treatment is recommended. Patients with New York Heart Association (NYHA) Class III and IV heart failure, recent myocardial infarction, and conduction abnormalities uncontrolled by medicinal products were not eligible for the clinical studies. These patients may be at greater risk for cardiac complications. Patients with signs or symptoms of NYHA Class III or IV cardiac failure, recent history of myocardial infarction (in the last 4 months), and in patients with uncontrolled angina or arrhythmias, should have a comprehensive cardiological assessment, prior to starting treatment with Carfilzomib. This assessment should optimise the patient’s status, with particular attention to blood pressure control and fluid management. Subsequently patients should be treated with caution and remain under close follow-up.
Electrocardiographic changes
There have been cases of QT interval prolongation reported in clinical studies and post-marketing Cases of ventricular tachycardia have been reported in patients receiving Carfilzomib.
Pulmonary toxicity
Acute respiratory distress syndrome (ARDS), acute respiratory failure, and acute diffuse infiltrative pulmonary disease such as pneumonitis and interstitial lung disease have occurred in patients receiving Carfilzomib Some of these events have been fatal. Evaluate and stop Carfilzomib until resolved and consider whether to restart Carfilzomib based on a benefit/risk assessment.
Pulmonary hypertension Pulmonary hypertension has been reported in patients treated with Carfilzomib. Some of these events have
been fatal. Evaluate as appropriate. Stop Carfilzomib for pulmonary hypertension until resolved or returned
to baseline and consider whether to restart Carfilzomib based on a benefit/risk assessment.
Dyspnoea was commonly reported in patients treated with Carfilzomib Evaluate dyspnoea to exclude diopulmonary conditions including cardiac failure and pulmonary syndromes. Stop Carfilzomib fur de 3 and 4 dyspnoea until resolved or returned to baseline and consider whether to restart Carfilzomib
Tell your doctor right away if you have chest pain, dizziness or lightheadedness, fainting, fast heartbeat, pain, redness, or swelling in the arm or legs, or trouble breathing. This medicine may cause infusion-related reactions, which can be life-threatening and require immediate medical attention.
