Campath 30 mg/mL
ALEMTUZUMAB · INJECTION · Genzyme Corporation
Campath is a injection containing alemtuzumab at 30 mg/mL, taken intravenous. Manufactured by Genzyme Corporation.
Key Facts
- Brand Name
- Campath
- Generic Name
- ALEMTUZUMAB
- NDC Code (Product)
58468-0357- Manufacturer
- Genzyme Corporation
- Strength
- 30 mg/mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- BLA103948
- Drug Class
- CD52-directed Cytolytic Antibody [EPC]
- Marketing Start
- 11/30/2009
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE CAMPATH is indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). CAMPATH is a CD52-directed cytolytic antibody indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Administer as an intravenous infusion over 2 hours. ( 2.1 ) Escalate to recommended dose of 30 mg/day three times per week for 12 weeks. ( 2.1 ) Premedicate with oral antihistamine and acetaminophen. ( 2.2 ) 2.1 Dosing Schedule and Administration Administer as an intravenous infusion over 2 hours. Do not administer as intravenous push or bolus. Recommended Dosing Regimen Gradually escalate to the maximum recommended single dose of 30 mg. Escalation is required at initiation of dosing or if dosing is held ≥7 days during treatment. Escalation to 30 mg ordinarily can be accomplished in 3 to 7 days. Escalation Strategy: – Administer 3 mg daily until infusion-related reactions are ≤ Grade 2 [see Adverse Reactions (6.1) ] . – Then administer 10 mg daily until infusion-related reactions are ≤ Grade 2. – Then administer 30 mg/day three times per week on alternate days (e.g., Mon-Wed-Fri). The total duration of therapy, including dose escalation, is 12 weeks. Single doses of greater than 30 mg or cumulative doses greater than 90 mg per week increase the incidence of pancytopenia. 2.2 Recommended Concomitant Medications Premedicate with diphenhydramine (50 mg) and…
Contraindications
4 CONTRAINDICATIONS None. None ( 4 )
Drug Interactions
7 DRUG INTERACTIONS No formal drug interaction studies have been performed with CAMPATH.
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of the label: Cytopenias [see Warnings and Precautions (5.1) ] Infusion-Related Reactions [see Warnings and Precautions (5.2) ] Immunosuppression/Infections [see Warnings and Precautions (5.3) ] Most common adverse reactions (≥10%): cytopenias, infusion-related reactions, cytomegalovirus (CMV) and other infections, nausea, emesis, diarrhea, and insomnia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Genzyme Corporation at 1-877-4-CAMPATH (1-877-422-6728) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data below reflect exposure to CAMPATH in 296 patients with CLL of whom 147 were previously untreated and 149 received at least 2 prior chemotherapy regimens. The median duration of exposure was 11.7 weeks for previously untreated patients and 8 weeks for prev…
Frequently Asked Questions
What is Campath used for?
Campath contains ALEMTUZUMAB. It is a injection taken intravenous. Consult your doctor for specific uses.
Is Campath a controlled substance?
Campath is not classified as a controlled substance by the DEA.
What is the generic name for Campath?
The generic name for Campath is ALEMTUZUMAB. There are 1 other brand versions of ALEMTUZUMAB.
What is the NDC code for Campath 30 mg/mL?
The NDC (National Drug Code) for Campath 30 mg/mL is 58468-0357, listed by Genzyme Corporation.