Campath

Included as part of the PRECAUTIONS section.

Pregnancy Category: C

Lactation: Unknown if excreted in human breast milk; a decision should be made whether to discontinue nursing or discontinue the drugs, taking into account the importance of the drug to the mother

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Campath is a prescription medication used to treat B-cell chronic lymphocytic leukemia (BCLL)- a type of cancer. Campath works by helping the immune system find and destroy cancer cells and it belongs to a group of drugs called monoclonal antibodies which target specific types of cancer cells. 

This medication comes in a liquid form and is injected intravenously (into a vein) by your doctor or healthcare provider. Your dose may require gradual increases beginning with low doses daily and eventually higher doses three times a week. A full course of Campath is usually about 12 weeks long.

Some of the common side effects of Campath include decreased blood count, skin rash, and an increased risk of infection.

• Genzyme Corporation

Campath is given to you through your veins (blood vessels).

• Your doctor will prescribe Campath in an amount that is right for you. 
• Your doctor will often treat you with several medications for your cancer. 
• It is very important that you follow your doctor's instructions closely. 
• Some medicines may be given to you before Campath to help prevent nausea, vomiting, itching, and other side effects

Initial treatment:

Campath is given through a thin plastic tube put into a vein (intravenous infusion or I.V.) and injected over 2 hours. You will be watched by a healthcare provider during this time. These injections will likely continue for several days before your doctor may change your dose amount or dose frequency.

Later treatment:

Campath is usually given for a total of 12 weeks. After initial treatment, Campath doses are often increased. The number of times you may receive Campath per week may decrease over time depending on your doctor's orders. At maximum dosage, Campath is usually given three times a week with a day of rest between each injection.

Call your doctor for instructions if you miss an appointment for your alemtuzumab injection.

Alemtuzumab is an antibody made from animal DNA.

Alemtuzumab is used to treat chronic B-cell lymphocytic leukemia or relapsing forms of multiple sclerosis.

Lemtrada is available only from a certified pharmacy under a special program. You must be registered in the program and understand the risks of taking this medicine.

Alemtuzumab may also be used for purposes not listed in this medication guide.

Call your doctor for instructions if you miss an appointment for your alemtuzumab injection.

Alemtuzumab injection is used to treat the relapsing forms of multiple sclerosis (MS). This medicine will not cure MS, but it may slow some of the disabling effects and decrease the number of relapses of the disease.

This medicine is only available through a restricted access program. Doctors who are enrolled in the restricted program can write a prescription for this medicine.

This section provides information on the proper use of a number of products that contain alemtuzumab. It may not be specific to Campath. Please read with care.

A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed into one of your veins.

This medicine is usually given for 2 treatment courses. You will receive this medicine for 5 consecutive days for the first treatment course and for 3 consecutive days about 1 year later for your second treatment course. Each treatment usually takes about 4 hours per day.

You will receive medicines to prevent allergic reactions (eg, steroids) before you start treatment with alemtuzumab.

You must enroll in a prescribing program called Lemtrada™ REMS program in order to begin receiving alemtuzumab. Your doctor will explain the program and have you sign an enrollment form. Be sure to ask your doctor if you have any questions about the Lemtrada™ REMS prescribing program. It is very important that you understand and follow all of the instructions for the program.

This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Dosing Schedule and Administration

• Administer as an IV 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 - 7 days.
  • Escalation Strategy:
    • Administer 3 mg daily until infusion reactions are ≤ grade 2 [see ADVERSE REACTIONS (6.1)].
    • Then administer 10 mg daily until infusion 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.

Recommended Concomitant Medications

• Premedicate with diphenhydramine (50 mg) and acetaminophen (500-1000 mg) 30 minutes prior to first infusion and each dose escalation. Institute appropriate medical management (e.g. steroids, epinephrine, meperidine) for infusion reactions as needed [see BOXED WARNING, WARNINGS AND PRECAUTIONS (5.2) and ADVERSE REACTIONS (6.1)].
• Administer trimethoprim/sulfamethoxazole DS twice daily (BID) three times per week (or equivalent) as Pneumocystis jiroveci pneumonia (PCP) prophylaxis.
• Administer famciclovir 250 mg BID or equivalent as herpetic prophylaxis.

Continue PCP and herpes viral prophylaxis for a minimum of 2 months after completion of Campath or until the CD4+ count is ≥ 200 cells/µL, whichever occurs later [see BOXED WARNING and WARNINGS AND PRECAUTIONS (5.3)].

Dose Modification

• Withhold Campath during serious infection or other serious adverse reactions until resolution.
• Discontinue Campath for autoimmune anemia or autoimmune thrombocytopenia.
• There are no dose modifications recommended for lymphopenia.

Preparation and Administration

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. If particulate matter is present or the solution is discolored, the vial should not be used. DO NOT SHAKE VIAL.

Use aseptic technique during the preparation and administration of Campath. Withdraw the necessary amount of Campath from the vial into a syringe.

• To prepare the 3 mg dose, withdraw 0.1 mL into a 1 mL syringe calibrated in increments of 0.01 mL.
• To prepare the 10 mg dose, withdraw 0.33 mL into a 1 mL syringe calibrated in increments of 0.01 mL.
• To prepare the 30 mg dose, withdraw 1 mL in either a 1 mL or 3 mL syringe calibrated in 0.1 mL increments.

Inject syringe contents into 100 mL sterile 0.9% Sodium Chloride USP or 5% Dextrose in Water USP. Gently invert the bag to mix the solution. Discard syringe.

The vial contains no preservatives and is intended for single use only. DISCARD VIAL including any unused portion after withdrawal of dose.

Use within 8 hours after dilution. Store diluted Campath at room temperature (15-30°C) or refrigerated (2-8°C). Protect from light.

Incompatibilities

Campath is compatible with polyvinylchloride (PVC) bags and PVC or polyethylene-lined PVC administration sets. Do not add or simultaneously infuse other drug substances through the same intravenous line.