Press Release Prescribing Information
Campath® Alemtuzumab - For Intravenous Use Only
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As a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL) - See Things in a Whole New Light: Campath First Line - Campath® Alemtuzumab For Intravenous Use Only
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Administering and Dosing

How Campath® (alemtuzumab) is administered and for how long

Campath is given intravenously (IV)—that is, injected directly into a vein. While the patient is getting Campath, you can talk, read, or listen to music with him/her. The patient will probably receive Campath at the doctor's office or a hospital clinic, and each treatment will take about 2 hours. However, the first few treatments may take longer because of the body's need to adjust gradually to Campath.

About 30 minutes before the patient gets Campath, he/she will be given other medications (such as acetaminophen or diphenhydramine, given orally, not IV) to help reduce side effects. As the caregiver you should go with the patient for the treatments, as the premedication could make him/her sleepy. On the first day, the patient will get a low dose (3 mg) of Campath. If he/she is able to tolerate the medication and the side effects are not serious, he/she will get a slightly higher dose (10 mg) the next day. This "dose escalation" will continue until the patient reaches the recommended dose (30 mg). Most patients are able to reach this dose in 3 to 7 days. After that, he/she will get 30 mg of Campath every other day, 3 days a week, for up to 12 weeks, as the doctor will decide.

Sample Treatment Schedule

Sample Schedule

During treatment, the patient may also receive anti-infective medications, such as trimethoprim/sulfamethoxale and famciclovir or a similar drug, which he/she will be asked to continue taking at home after therapy has been completed.

Indication and Important Safety Information

Campath is indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL).

WARNING: CYTOPENIAS, INFUSION REACTIONS, and INFECTIONS

Cytopenias: Serious, including fatal, pancytopenia/marrow hypoplasia, autoimmune idiopathic thrombocytopenia, and autoimmune hemolytic anemia can occur in patients receiving Campath. Single doses of Campath greater than 30 mg or cumulative doses greater than 90 mg per week increase the incidence of pancytopenia [see WARNINGS AND PRECAUTIONS (5.1)].

Infusion Reactions: Campath administration can result in serious, including fatal, infusion reactions. Carefully monitor patients during infusions and withhold Campath for Grade 3 or 4 infusion reactions. Gradually escalate Campath to the recommended dose at the initiation of therapy and after interruption of therapy for 7 or more days [see DOSAGE AND ADMINISTRATION (2) and WARNINGS AND PRECAUTIONS (5.2)].

Infections: Serious, including fatal, bacterial, viral, fungal, and protozoan infections can occur in patients receiving Campath. Administer prophylaxis against Pneumocystis jiroveci pneumonia (PCP) and herpes virus infections [see DOSAGE AND ADMINISTRATION (2.2) and WARNINGS AND PRECAUTIONS (5.3)].

The most commonly reported adverse reactions are infusion reactions fever, chills, hypotension, urticaria, nausea, rash, tachycardia, dyspnea), cytopenias (neutropenia, lymphopenia, thrombocytopenia, anemia), and infections (CMV viremia, CMV infection, other infections). In clinical trials, the frequency of infusion reactions was highest in the first week of treatment. Other commonly reported adverse reactions include vomiting, abdominal pain, insomnia and anxiety. The most commonly reported serious adverse reactions are cytopenias, infusion reactions, and immunosuppression/infections. See "Warnings and Precautions," and "Adverse Reactions" sections of full Prescribing Information.

Please see Full Prescribing Information (PDF).