Campath

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• Consumer Information
• Professional Information

 

Campath Side Effects Center

What Is Campath?

Campath (alemtuzumab) is an antibody made from animal DNA used to treat chronic lymphocytic leukemia. Campath is usually given after other medications have been tried without successful treatment.

What Are Side Effects of Campath?

Common side effects of Campath include:

• fever,
• chills,
• dizziness,
• muscle stiffness,
• joint or muscle pain,
• nausea,
• vomiting,
• loss of appetite,
• abdominal pain,
• headache,
• diarrhea,
• rash or itching,
• hives,
• tiredness,
• sleep problems (insomnia),
• anxiety,
• fatigue,
• cough,
• sweating, or
• trouble breathing during or after the infusion.

These side effects occur more often during the first week of treatment with Campath. Tell your doctor if you have serious side effects of Campath including:

• shortness of breath,
• mental/mood changes (such as depression, anxiety),
• bone or back pain,
• muscle spasm,
• unusual weakness,
• swelling ankles or feet,
• yellowing skin or eyes,
• changes in the amount of urine,
• painful urination,
• pink or bloody urine,
• numbness or tingling of arms or legs, or
• pain/redness/swelling of arms/legs/injection site.

Dosage for Campath

Campath medication is given intravenously under physician supervision, usually over 2 hours. Dosage is based on the patient's response to treatment. Patients are usually started on a low dose of the medication, and the dose may be slowly increased.

What Drugs, Substances, or Supplements Interact with Campath?

Other drugs may affect Campath. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Campath During Pregnancy and Breastfeeding

During pregnancy, Campath should be used only when prescribed. It is recommended that men and women receiving this medication use at least 2 forms of birth control (e.g., condoms, birth control pills) during treatment with this medication and for at least 6 months afterwards. It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding while using this drug is not recommended during treatment with this medication and for at least 3 months afterwards.

Additional Information

Our Campath (alemtuzumab) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Campath Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during or shortly after the injection. Tell your caregiver if you feel weak, feverish, chilled, dizzy, nauseated, light-headed, or have a rash, wheezing, chest pain, trouble breathing, swelling in your mouth or throat, or fast, slow, or irregular heartbeats.

Alemtuzumab can cause your immune system to attack cells and organs in your body. This can lead to serious medical problems that may occur months to years after you receive Campath or Lemtrada. Call your doctor at once if you have:

• unusual bleeding or bruising, nosebleeds, bleeding gums, heavy menstrual periods, blood in your urine or stools, coughing up blood;
• problems with speech, thought, vision, or muscle movement;
• a mole that has changed in size or color;
• cough, wheezing, chest pain, feeling short of breath, coughing up blood;
• an overactive immune system--fever, swollen glands, rash, feeling unsteady or less alert, trouble waking, seizure;
• liver problems--loss of appetite, stomach pain (upper right side), dark urine, jaundice (yellowing of the skin or eyes); or
• kidney problems--swelling in your lower legs, weight gain, loss of appetite, sudden pain in your stomach and back, urine that looks pink/brown or foamy;
• signs of infection--fever, chills, sore throat, cough, mouth sores, skin sores or blisters, tingling, burning pain, pale or yellowed skin, pain or burning when you urinate, dark urine, feeling light-headed, cold hands and feet;
• signs of tuberculosis--cough, night sweats, loss of appetite, weight loss, and feeling very tired;
• signs of a stroke or tear in an artery--sudden severe headache, weakness on one side of your body, drooping in your face, slurred speech;
• gallbladder problems--fever, nausea, vomiting, and stomach pain;
• thyroid problems--sweating, feeling cold, fast heartbeats, feeling nervous or tired, eye swelling, weight gain or loss; or
• symptoms of thyroid cancer--a lump or swelling in your neck or throat, trouble swallowing, hoarse voice, or a new cough (not caused by a cold).

Common side effects may include:

• reactions to the injection;
• stomach pain, nausea, vomiting, diarrhea;
• infections (fever, chills, runny or stuffy nose, mouth or throat pain, painful urination);
• chest pain or tightness, coughing up blood;
• rash, itching, tingling, hives;
• dizziness, tiredness, trouble sleeping;
• headache, joint pain, back pain, pain in your arms or legs;
• thyroid problems; or
• flushing (sudden warmth, redness, or tingly feeling).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Campath (Alemtuzumab)

 

Campath Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are discussed in greater detail in other sections of the label:

• Cytopenias [see WARNINGS AND PRECAUTIONS]
• Infusion-Related Reactions [see WARNINGS AND PRECAUTIONS]
• Immunosuppression/Infections [see WARNINGS AND PRECAUTIONS]

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 previously treated patients.

The most common adverse reactions with CAMPATH are: infusion-related reactions (pyrexia, chills, hypotension, urticaria, nausea, rash, tachycardia, dyspnea), cytopenias (neutropenia, lymphopenia, thrombocytopenia, anemia), infections (CMV viremia, CMV infection, other infections), gastrointestinal symptoms (nausea, emesis, abdominal pain), and neurological symptoms (insomnia, anxiety). The most common serious adverse reactions are cytopenias, infusion-related reactions, and immunosuppression/infections.

Lymphopenia

Severe lymphopenia and a rapid and sustained decrease in lymphocyte subsets occurred in previously untreated and previously treated patients following administration of CAMPATH. In previously untreated patients, the median CD4+ was 0 cells/μL at one month after treatment and 238 cells/μL [25%-75% interquartile range 115 to 418 cells/μL at 6 months post treatment [see WARNINGS AND PRECAUTIONS].

Neutropenia

In previously untreated patients, the incidence of Grade 3 or 4 neutropenia was 42% with a median time to onset of 31 days and a median duration of 37 days. In previously treated patients, the incidence of Grade 3 or 4 neutropenia was 64% with a median duration of 28 days. Ten percent of previously untreated patients and 17% of previously treated patients received granulocyte colony stimulating factors.

Anemia

In previously untreated patients, the incidence of Grade 3 or 4 anemia was 12% with a median time to onset of 31 days and a median duration of 8 days. In previously treated patients, the incidence of Grade 3 or 4 anemia was 38%. Seventeen percent of previously untreated patients and 66% of previously treated patients received either erythropoiesis stimulating agents, transfusions or both.

Thrombocytopenia

In previously untreated patients, the incidence of Grade 3 or 4 thrombocytopenia was 14% with a median time to onset of 9 days and a median duration of 14 days. In previously treated patients, the incidence of Grade 3 or 4 thrombocytopenia was 52% with a median duration of 21 days. Autoimmune thrombocytopenia was reported in 2% of previously treated patients with one fatality.

Infusion-Related Reactions

Infusion-related reactions, which included pyrexia, chills, hypotension, urticaria, and dyspnea, were common. Grade 3 and 4 pyrexia and/or chills occurred in approximately 10% of previously untreated patients and in approximately 35% of previously treated patients. The occurrence of infusion-related reactions was greatest during the initial week of treatment and decreased with subsequent doses of CAMPATH. All patients were pretreated with antipyretics and antihistamines; additionally, 43% of previously untreated patients received glucocorticoid pretreatment.

Infections

In the study of previously untreated patients, patients were tested weekly for CMV using a PCR assay from initiation through completion of therapy, and every 2 weeks for the first 2 months following therapy. CMV infection occurred in 16% (23/147) of previously untreated patients; approximately one-third of these infections were serious or life threatening. In studies of previously treated patients in which routine CMV surveillance was not required, CMV infection was documented in 6% (9/149) of patients; nearly all of these infections were serious or life threatening.

Other infections were reported in approximately 50% of patients across all studies. Grade 3 to 5 sepsis ranged from 3% to 10% across studies and was higher in previously treated patients. Grade 3 to 4 febrile neutropenia ranged from 5% to 10% across studies and was higher in previously treated patients. Infection-related fatalities occurred in 2% of previously untreated patients and 16% of previously treated patients. There were 198 episodes of other infection in 109 previously untreated patients; 16% were bacterial, 7% were fungal, 4% were other viral, and in 73% the organism was not identified.

Cardiac

Cardiac dysrhythmias occurred in approximately 14% of previously untreated patients. The majority were tachycardias and were temporally associated with infusion; dysrhythmias were Grade 3 or 4 in 1% of patients.

Previously Untreated Patients

Table 1 contains selected adverse reactions observed in 294 patients randomized (1:1) to receive CAMPATH or chlorambucil as first line therapy for B-CLL. CAMPATH was administered at a dose of 30 mg intravenously three times weekly for up to 12 weeks. The median duration of therapy was 11.7 weeks with a median weekly dose of 82 mg (25%-75% interquartile range: 6990 mg).

Table 1: Per Patient Incidence of Selected¹ Adverse Reactions in Treatment Naive B-CLL Patients

		CAMPATH (n=147)		Chlorambucil (n=147)
		All Grades2 %	Grades 3-4 %	All Grades %	Grades 3-4 %
Blood and Lymphatic System Disorders	Lymphopenia	97	97	9	1
	Neutropenia	77	42	51	26
	Anemia	76	13	54	18
	Thrombocytopenia	71	13	70	14
General Disorders and Administration Site Conditions	Pyrexia	69	10	11	1
	Chills	53	3	1	0
Infections and Infestations	CMV viremia3	55	4	8	0
	CMV infection	16	5	0	0
	Other infections	74	21	65	10
Skin and Subcutaneous Tissue Disorders	Urticaria	16	2	1	0
	Rash	13	1	4	0
	Erythema	4	0	1	0
Vascular Disorders	Hypotension	16	1	0	0
	Hypertension	14	5	2	1
Nervous System Disorders	Headache	14	1	8	0
	Tremor	3	0	1	0
Respiratory, Thoracic and Mediastinal Disorders	Dyspnea	14	4	7	3
Gastrointestinal Disorders	Diarrhea	10	1	4	0
Psychiatric Disorders	Insomnia	10	0	3	0
	Anxiety	8	0	1	0
Cardiac Disorders	Tachycardia	10	0	1	0
1 Adverse reactions occurring at a higher relative frequency in the CAMPATH arm 2 NCI CTC version 2.0 for adverse reactions; NCI CTCAE version 3.0 for laboratory values 3 CMV viremia (without evidence of symptoms) includes both cases of single PCR positive test results and of confirmed CMV viremia (≥2 occasions in consecutive samples 1 week apart). For the latter, ganciclovir (or equivalent) was initiated per protocol.

Previously Treated Patients

Additional safety information was obtained from 3 single arm studies of 149 previously treated patients with CLL administered 30 mg CAMPATH intravenously three times weekly for 4 to 12 weeks (median cumulative dose 673 mg [range 2-1106 mg]; median duration of therapy 8.0 weeks). Adverse reactions in these studies not listed in Table 1 that occurred at an incidence rate of >5% were fatigue, nausea, emesis, musculoskeletal pain, anorexia, dysesthesia, mucositis, and bronchospasm.

Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity. The incidence of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies with the incidence of antibodies to other alemtuzumab products may be misleading.

Using an ELISA assay, anti-human antibodies (HAHA) were detected in 11 of 133 (8.3%) previously untreated patients. In addition, two patients were weakly positive for neutralizing activity. Limited data suggest that the anti-CAMPATH antibodies did not adversely affect tumor response. Four of 211 (1.9%) previously treated patients were found to have antibodies to CAMPATH following treatment.

Postmarketing Experience

CAMPATH

The following adverse reactions have been identified during postapproval use of CAMPATH. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

General Disorders and Administration Site Conditions: Fatal infusion-related reactions.

Cardiovascular Disorders: Congestive heart failure, cardiomyopathy, decreased ejection fraction (some patients had been previously treated with cardiotoxic agents).

Cerebrovascular Disorders: Cervicocephalic arterial dissection, stroke, including hemorrhagic and ischemic stroke.

Gastrointestinal Disorders: Acute acalculous cholecystitis.

Immune System Disorders: Goodpasture's syndrome, Graves' disease, aplastic anemia, Guillain Barre syndrome, chronic inflammatory demyelinating polyradiculoneuropathy, serum sickness, fatal transfusion associated graft versus host disease, hemophagocytic lymphohistiocytosis (HLH).

Infections: Epstein-Barr virus (EBV) infection, progressive multifocal leukoencephalopathy (PML), reactivation of latent viruses.

Metabolism and Nutrition Disorders: Tumor lysis syndrome.

Neoplasms: EBV-associated lymphoproliferative disorder.

Nervous System Disorders: Optic neuropathy.

Renal and Urinary Disorders: Glomerular nephropathies.

Other Alemtuzumab Products

The following adverse reactions have been identified during postapproval use of another alemtuzumab product. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Endocrine Disorders: Hypothyroidism, hyperthyroidism, and thyroiditis.

DRUG INTERACTIONS

No formal drug interaction studies have been performed with CAMPATH.

Read the entire FDA prescribing information for Campath (Alemtuzumab)

&Copy; Campath Patient Information is supplied by Cerner Multum, Inc. and Campath Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.