Product Description
1. Technical Specifications
| Attribute |
Details |
| Brand Name |
Campath 30 mg/mL Injection |
| Generic Name |
Alemtuzumab |
| Strength |
30 mg/mL (concentrate for infusion) |
| Dosage Form |
Intravenous Infusion (IV) |
| Packaging Size |
1 vial (1 mL solution containing 30 mg of Alemtuzumab) |
| Packaging Type |
Glass vial with rubber stopper and flip-off seal |
| Medicine Type |
Monoclonal Antibody (Immunotherapy) |
| Manufacturer |
Genzyme Corporation (Sanofi) |
| Distributed By |
Authorized specialty oncology/immunotherapy distributors |
2. Product Description
Campath (Alemtuzumab) is a recombinant humanized monoclonal antibody targeting the CD52 antigen present on B and T lymphocytes.
By binding to CD52, it induces cell lysis via antibody-dependent cellular cytotoxicity and complement-mediated cytotoxicity, leading to profound lymphocyte depletion.
It is indicated for:
-
B-cell Chronic Lymphocytic Leukemia (B-CLL) in patients who have been treated with alkylating agents and have failed fludarabine therapy.
-
Also studied and used off-label in multiple sclerosis (MS) (though marketed as Lemtrada for MS).
3. Product Highlights
| Attribute |
Details |
| Therapeutic Category |
Antineoplastic / Immunotherapy (Monoclonal Antibody) |
| Application Area |
B-cell Chronic Lymphocytic Leukemia (B-CLL); off-label in autoimmune diseases (MS, transplant conditioning) |
| Mechanism of Action |
Binds to CD52 on lymphocytes triggers immune-mediated lysis rapid and sustained lymphocyte depletion reduction of malignant or autoreactive immune cells |
| Administration |
IV infusion only. Usual schedule: 3 mg starting dose, escalated to 30 mg three times per week for up to 12 weeks (depending on patient tolerance). Must be diluted in 100 mL 0.9% sodium chloride or 5% dextrose and infused over 2 hours. |
| Storage Conditions |
Store at 28 C (refrigerated). Do not freeze or shake. Protect from light. |
4. Therapeutic Uses
5. Side Effects
Common:
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Infusion-related reactions (fever, chills, rash, hypotension)
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Nausea, vomiting, diarrhea
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Fatigue, headache, dizziness
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Cytopenias (anemia, neutropenia, lymphopenia)
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Infections (upper respiratory, urinary tract, herpes reactivation)
Serious / Severe:
-
Severe myelosuppression (neutropenia, thrombocytopenia)
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Opportunistic infections (CMV reactivation, PCP, fungal infections, sepsis)
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Autoimmune complications (thyroid disorders, immune thrombocytopenia, hemolytic anemia)
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Malignancy risk (thyroid cancer, melanoma, lymphomas)
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Rare but life-threatening anaphylaxis or infusion reaction
6. Precautions
-
Premedication: Corticosteroids, antihistamines, and antipyretics recommended prior to infusion.
-
Infection Prophylaxis: Antiviral (e.g., acyclovir) and antibacterial (e.g., TMP-SMX for PCP) prophylaxis required during treatment and for several months after.
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CBC & Monitoring: Regular blood counts to detect cytopenias; monitor for autoimmune events.
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Vaccinations: Live vaccines contraindicated during and after treatment until immune recovery.
-
Pregnancy & Breastfeeding: Contraindicated; effective contraception required during and after therapy.
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Administration Setting: Hospital/oncology center with resuscitation facilities due to risk of infusion reactions.
Precision in TreatmentCampath Alemtuzumab is formulated for adult patients, with each dosage tailored by healthcare professionals based on individual requirements. Its efficacy relies on accurate administration, which must always follow a doctors guidance to ensure patient safety and optimal therapeutic results.
Safe Storage RecommendationsTo maintain the quality of Campath Alemtuzumab, store the injection in a cool, dry place away from direct sunlight. Proper storage is vital in preserving the drugs integrity, preventing degradation, and ensuring its effectiveness with each use.
Trusted Distribution NetworkThis injection is available through a network of authorized distributors, exporters, suppliers, traders, and wholesalers across India. Qualified healthcare professionals should be consulted for purchasing and administering the medication to ensure compliance with medical and regulatory standards.
FAQs of Campath Alemtuzumab 30 mg/ml Injection:
Q: How should Campath Alemtuzumab Injection be administered?
A: Campath Alemtuzumab Injection is given as an intravenous infusion and must be administered by a qualified healthcare professional. Never attempt to use this product without medical supervision.
Q: What is the correct dosage for Campath Alemtuzumab Injection?
A: The dosage of Campath Alemtuzumab should always be as per doctors instructions. Each patients treatment is individualized, and only a healthcare provider can determine the appropriate dosage schedule.
Q: When should I use Campath Alemtuzumab Injection?
A: This medication is used when prescribed by a doctor for specific medical conditions. Always follow your physicians directions regarding timing and frequency of administration.
Q: Where should Campath Alemtuzumab Injection be stored?
A: Store this injection in a cool and dry place, away from moisture and direct light. Proper storage helps maintain the stability and potency of the drug.
Q: What is the benefit of using Campath Alemtuzumab Injection?
A: Campath Alemtuzumab is used under medical supervision for its therapeutic benefits in treating select conditions. Its use can lead to significant clinical improvements as determined by your doctor.
Q: Who is suitable for Campath Alemtuzumab Injection?
A: This medication is suitable for adults and should only be administered to patients under direct medical supervision.
Q: What is the process for obtaining Campath Alemtuzumab Injection in India?
A: Campath Alemtuzumab can be procured through licensed distributors, exporters, suppliers, traders, or wholesalers. Always ensure you obtain it from reputable sources and under a doctors prescription.