Kempas

Kempas is indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS). Because of its safety profile, the use of Kempas should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS.

Kempas is an antibody made from animal DNA.

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

Kempas 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.

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

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.
    • 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.
• 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 Kempas or until the CD4+ count is > 200 cells/^L, whichever occurs later.

Dose Modification

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

Dose Modification for Neutropenia or Thrombocytopenia

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 Kempas. Withdraw the necessary amount of Kempas 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 Kempas at room temperature (15-30°C) or refrigerated (2-8°C). Protect from light.

Incompatibilities

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

How supplied

Dosage Forms And Strengths

30 mg/1 mL single use vial

Storage And Handling

Kempas (Kempas) is supplied in single-use clear glass vials containing 30 mg of Kempas in 1 mL of solution. Each carton contains three Kempas vials (NDC 58468-0357-3) or one Kempas vial (NDC 58468-0357-1).

Store Kempas at 2-8°C (36-46°F). Do not freeze. If accidentally frozen, thaw at 2-8°C before administration. Protect from direct sunlight.

Manufactured and distributed by: Genzyme Corporation, Cambridge, MA 02142. Revised: Sep 2014

See also:
What is the most important information I should know about Kempas?

You should not receive Kempas if you are allergic to it.

Before you receive Kempas, tell your doctor if you have any type of infection, if you are allergic to mouse or hamster proteins, or if you have regular blood transfusions.

Kempas can lower blood cells that help your body fight infections and help your blood to clot. Your blood may need to be tested often. Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding injury. Tell your doctor at once if you develop signs of infection.

Serious and sometimes fatal infections may occur during treatment with Kempas. Call your doctor right away if you have signs of infection such as: fever, cough, sweating, tired feeling, weakness, confusion, easy bruising or bleeding (nosebleed, bleeding gums), feeling light-headed or short of breath, rapid heart rate, pale or yellowed skin, or dark colored urine.

Do not receive a "live" vaccine while using Kempas. The vaccine may not work as well during this time, and may not fully protect you from disease.

You may be given other medications together with Kempas to help prevent infection or certain side effects. Take these medicines for the full prescribed length of time.

You should not breast-feed while you are receiving Kempas.

Use Kempas as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Kempas comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Kempas refilled.
• Kempas is given as an injection at your doctor's office, hospital, or clinic. Contact your health care provider if you have any questions.
• Your doctor may give you other medicines before you receive Kempas to help reduce the risk of an infusion reaction. Talk with your doctor.
• If you miss a dose of Kempas, call your doctor to find out what to do.

Ask your health care provider any questions you may have about how to use Kempas.

Kempas is used to treat a certain type of leukemia (B-cell chronic lymphocytic leukemia, also known as B-CLL). This medication works by stopping the growth of cancer cells.

Kempas is also used to treat a certain type of multiple sclerosis (relapsing multiple sclerosis-MS). It is not a cure for MS but it is thought to help by preventing immune system cells (lymphocytes) from attacking the nerves in your brain and spinal cord. It helps decrease the number of episodes of worsening and may prevent or delay disability.

How to use Kempas intravenous

Read the Medication Guide, Patient Safety Information Card, and, if available, the Patient Information Leaflet provided by your pharmacist before you start using Kempas and each time you receive treatment with this drug. Carry the Patient Safety Information Card with you at all times. If you have any questions, ask your doctor or pharmacist.

This medication is given by slow injection into a vein by a health care professional. The dosage and treatment schedule is based on your medical condition and response to treatment. If you are using this medication to treat B-cell chronic lymphocytic leukemia, your doctor will increase your dose slowly to decrease the risk of side effects.

Before you receive this medication, your doctor will direct you to take other medications (such as acetaminophen, diphenhydramine) to help prevent side effects. Your doctor should also prescribe other medications (such as antibiotics, antiviral medications) to help prevent infection in your body. Use these additional medications exactly as prescribed by your doctor.

See also:
What other drugs will affect Kempas?

May reduce efficacy of inactivated vaccines. Not recommended for use w/in 3 wk of other chemotherapy drugs. Live viral vaccines should not be used for at least 12 mth after Kempas therapy.

See also:
What are the possible side effects of Kempas?

The following serious adverse reactions are described below and elsewhere in the labeling:

• Autoimmunity
• Infusion reactions
• Malignancies
• Immune Thrombocytopenia
• Glomerular Nephropathies
• Thyroid Disorder
• Other Autoimmune Cytopenias
• Infections
• Pneumonitis

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.

In controlled clinical trials (Study 1 and Study 2), a total of 811 patients with relapsing forms of MS received Kempas. A total of 811 patients received 1 course of therapy, and 789 patients received a second course of therapy at 12 months. The overall follow-up in the controlled trials was equivalent to 1622 patient years, with an additional 3411 person-years of follow-up in an open label extension study. The population was 18-55 years of age, 65% were female, and 92% were Caucasian.

Most Common Adverse Reactions

In clinical trials, the most common adverse reactions with Kempas (in at least 10% of patients and more frequently than in interferon beta-1a) were rash, headache, pyrexia, nasopharyngitis, nausea, urinary tract infection, fatigue, insomnia, upper respiratory tract infection, herpes viral infection, urticaria, pruritus, thyroid gland disorders, fungal infection, arthralgia, pain in extremity, back pain, diarrhea, sinusitis, oropharyngeal pain, paresthesia, dizziness, abdominal pain, flushing, and vomiting.

Table 1 lists adverse reactions occurring in ≥5% of Kempas-treated patients in Study 1 and 2 and at the same or at a higher rate than interferon beta-1a.

Lymphopenia

Nearly all (99.9%) patients treated with Kempas in MS clinical trials experienced lymphopenia. The lowest lymphocyte counts occurred approximately by 1 month after each course of treatment. The mean lymphocyte count at 1 month after Kempas treatment was 0.25 × 109L (range 0.02-2.30 × 109L) and 0.32 (0.02-1.81 × 109L) for treatment courses 1 and 2, respectively. Total lymphocyte counts increased to reach the lower limit of normal in approximately 40% of patients by 6 months after each Kempas treatment course and approximately 80% of patients by 12 months after each course.

Suicidal Behavior or Ideation

In clinical studies, 0.6% of patients in both the Kempas and interferon beta-1a groups had events of attempted suicide or suicidal ideation. There were no completed suicides in either clinical study treatment group. Suicidal behavior or ideation occurred in patients with or without a history of a psychiatric or thyroid disorder. Advise patients to report immediately any symptoms of depression or suicidal ideation to the prescribing physician.

Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity. Using an enzyme-linked immunosorbent assay (ELISA) and a competitive binding assay, anti-Kempas binding antibodies were detected in 62%, 67%, and 29% of Kempas-treated patients, at months 1, 3, 12 (Course 1) as well as 83%, 83%, and 75% of Kempas-treated patients at months 13, 15, and 24 (Course 2). Samples that tested positive for binding antibodies were further evaluated for evidence of in vitro inhibition using a flow cytometry assay. Neutralizing antibodies were detected in 87%, 46%, and 5% of positive binding antibody patients at months 1, 3, 12 (Course 1) as well as 94%, 88%, and 42% of positive binding antibody patients at months 13, 15, and 24 (Course 2). Anti-Kempas antibodies were associated with decreased Kempas concentration during Course 2 but not Course 1. There was no evidence from clinical trials that the presence of binding or inhibitory anti-Kempas antibodies had a significant effect on clinical outcomes, total lymphocyte count, or adverse events.

The incidence of antibodies is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including inhibitory 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 to Kempas with the incidence of antibodies to other products may be misleading.

Postmarketing Experience

The following adverse reactions, not described elsewhere, were identified during post-approval use of Kempas for the treatment of B-cell chronic lymphocytic leukemia (B-CLL), as well as for the treatment of other disorders, generally at higher and more frequent doses (e.g., 30 mg) than that recommended in the treatment of MS. 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.

Cardiac Disorders

Congestive heart failure, cardiomyopathy, and decreased ejection fraction in non-MS patients previously treated with potentially cardiotoxic agents.