Drug: Amevive
AMEVIVE® (alefacept) is a CD2-directed LFA-3/Fc fusion protein that consists of the extracellular CD2-binding portion of the human leukocyte function antigen-3 (LFA-3) linked to the Fc (hinge, CH2 and CH3 domains) portion of human IgGl. Alefacept is produced by recombinant DNA technology in a Chinese Hamster Ovary (CHO) mammalian cell expression system. The molecular weight of alefacept is 91.4 kilodaltons. AMEVIVE® is supplied as a sterile, white-to-off-white, preservative-free, lyophilized powder for intramuscular administration. After reconstitution with 0.6 mL of the supplied Sterile Water for Injection, USP, the solution of AMEVIVE® is clear, with a pH of approximately 6.9. AMEVIVE® for intramuscular injection contains alefacept (15 mg), citric acid monohydrate (0.06 mg), glycine (5 mg), sodium citrate dehydrate (3.6 mg), and sucrose (12.5 mg) per 0.5 mL of reconstituted solution.
Source: http://www.rxlist.com
The most serious adverse reactions described elsewhere in the labeling include the following:
- Lymphopenia [see WARNINGS AND PRECAUTIONS]
- Malignancies [see WARNINGS AND PRECAUTIONS]
- Serious Infections requiring hospitalization [see WARNINGS AND PRECAUTIONS]
- Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
Source: http://www.rxlist.com
Dosing Instructions The recommended dose of AMEVIVE® is 15 mg intramuscularly once weekly for 12 weeks. The CD4+ T lymphocyte counts should be measured before initiating dosing. AMEVIVE® therapy should not be initiated in patients who have CD4+ T lymphocyte counts below normal. The CD4+ T lymphocyte counts of patients receiving AMEVIVE® should be monitored every two weeks throughout the course of the 12-week dosing regimen. If CD4+ T lymphocyte counts are below 250 cells/µL, AMEVIVE® dosing should be withheld and weekly monitoring instituted. AMEVIVE® should be discontinued if the counts remain below 250 cells/µL for one month [see WARNINGS AND PRECAUTIONS]. An additional 12-week course may be initiated if at least 12-weeks have passed since the previous treatment course and the CD4+ T lymphocyte counts are normal. Preparation Instructions
- AMEVIVE® should be reconstituted using aseptic technique. Each vial is for single patient use only.
- AMEVIVE® 15 mg lyophilized powder should only be reconstituted with the supplied diluent (Sterile Water for Injection)
- Do not add other medications to solutions containing AMEVIVE®. Do not filter reconstituted solution during preparation or administration.
- Using the supplied syringe and one of the supplied needles, withdraw 0.6 mL of the diluent. Keeping the needle pointed at the sidewall of the vial, slowly inject the diluent into the vial of AMEVIVE®. Foaming will occur. Gently swirl the contents during dissolution. To avoid excessive foaming, do not shake or vigorously agitate. Dissolution of AMEVIVE® generally takes less than two minutes.
- Inspect AMEVIVE® reconstituted solution visually for particulate matter and discoloration. AMEVIVE® reconstituted solution should be clear and colorless to slightly yellow. The solution should not be used if it is cloudy, if there is pronounced discoloration, or if particulate matter is present.
- The reconstituted product should be used immediately or within 4 hours if stored in the vial at 2-8°C (36-46°F). Discard AMEVIVE® not used within 4 hours of reconstitution.
- The reconstituted solution should be clear and colorless to slightly yellow. Do not administer the solution if cloudy or discolored or if undissolved material or particulate matter is present.
- Remove the needle used for reconstitution and attach the other supplied needle. Withdraw 0.5 mL of the AMEVIVE® solution into the syringe, and inject the full 0.5 mL of solution intramuscularly. A volume of 0.5 mL of the reconstituted solution contains 15 mg of alefacept. Rotate injection sites so that a different site is used for each new injection. New injections should be given at least one inch from a previous injection site and never into tender, bruised, erythematous, or indurated skin.
- Discard empty vials of AMEVIVE®.
Source: http://www.rxlist.com
Drug interaction studies have not been conducted with AMEVIVE®. Concomitant Therapies The safety of AMEVIVE® in combination with immunosuppressive agents or phototherapy has not been evaluated [see WARNINGS AND PRECAUTIONS]. CYP450 Substrates The formation of CYP450 enzymes may be suppressed by increased levels of cytokines (e.g., TNFα, IL-1, IL-6, IL-10, IFN) during chronic inflammation. Therefore, a molecule that exerts its pharmacological effect by inhibiting the release of cytokines, such as AMEVIVE®, could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of AMEVIVE® in patients being treated with CYP450 substrates with a narrow therapeutic index, monitoring of the effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) is recommended and the individual dose of the drug product may be adjusted as needed.Read the Amevive Drug Interactions Center for a complete guide to possible interactions Learn More »
Source: http://www.rxlist.com
AMEVIVE® is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.
Source: http://www.rxlist.com
AMEVIVE® should not be administered to patients infected with HIV. AMEVIVE® reduces CD4+ T lymphocyte counts, which might accelerate disease progression or increase complications of disease in these patients [see WARNINGS AND PRECAUTIONS]. Last reviewed on RxList: 6/8/2012
This monograph has been modified to include the generic and brand name in many instances.
This monograph has been modified to include the generic and brand name in many instances.
Source: http://www.rxlist.com
The highest dose tested in humans (0.75 mg/kg intravenous) was associated with chills, headache, arthralgia, and sinusitis within one day of dosing. Patients who have been inadvertently administered an excess of the recommended dose should be closely monitored for effects on total lymphocyte count and CD4+ T lymphocyte count.
Source: http://www.rxlist.com
Dosage Forms and Strengths For injection; AMEVIVE® is supplied as 15 mg of lyophilized powder in a single-use vial for reconstitution with Sterile Water for Injection, USP. AMEVIVE® (alefacept) is a sterile, white to off-white, preservative-free lyophilizate (15 mg/vial) for intramuscular administration provided in single-use glass vials with a bromobutyl rubber stopper and an aluminum overseal. Each vial contains 15 mg of alefacept. AMEVIVE® is available as follows: Carton Contents NDC One- 5 mg single-use AMEVIVE® vial
One - 10 mL single-use diluent vial of Sterile Water for Injection, USP
One- 1 mL syringe
Two- 23 gauge 1 1/4 inch needles 0469-0021-04 Four -15 mg single-use AMEVIVE® vials
Four -10 mL single-use diluent vials of Sterile Water for Injection, USP
Four- 1 mL syringes
Eight- 23 gauge 1 1/4 inch needles 0469-0021-03 Store AMEVIVE® refrigerated between 2-8°C (36-46°F). Do not freeze. Store in carton until use to protect from light. AMEVIVE® (alefacept) Manufactured by: Astellas Pharma US, Inc. Deerfield,IL 60015. Revised: 05/2012Last reviewed on RxList: 6/8/2012
This monograph has been modified to include the generic and brand name in many instances.
One - 10 mL single-use diluent vial of Sterile Water for Injection, USP
One- 1 mL syringe
Two- 23 gauge 1 1/4 inch needles 0469-0021-04 Four -15 mg single-use AMEVIVE® vials
Four -10 mL single-use diluent vials of Sterile Water for Injection, USP
Four- 1 mL syringes
Eight- 23 gauge 1 1/4 inch needles 0469-0021-03 Store AMEVIVE® refrigerated between 2-8°C (36-46°F). Do not freeze. Store in carton until use to protect from light. AMEVIVE® (alefacept) Manufactured by: Astellas Pharma US, Inc. Deerfield,IL 60015. Revised: 05/2012Last reviewed on RxList: 6/8/2012
This monograph has been modified to include the generic and brand name in many instances.
Source: http://www.rxlist.com
Lymphopenia AMEVIVE® induces dose-dependent reductions in circulating CD4+ and CD8+ T lymphocyte counts. CD4+ counts should be normal before initiating treatment with AMEVIVE® and should be closely monitored during AMEVIVE® treatment [see DOSAGE AND ADMINISTRATION] Malignancies AMEVIVE® may increase the risk of malignancies. Malignancies were reported in subjects who received AMEVIVE® in clinical studies [see ADVERSE REACTIONS]. In preclinical studies, animals developed B cell hyperplasia, and one animal developed a lymphoma [see Nonclinical Toxicology]. AMEVIVE® should not be administered to patients with a history of systemic malignancy. Exercise caution when considering the use of AMEVIVE® in patients at high risk for malignancy. Discontinue AMEVIVE® if a patient develops a malignancy. Serious Infections AMEVIVE® is an immunosuppressive agent and, therefore, has the potential to increase the risk of infection and reactivate latent, chronic infections. Serious infections (infections requiring hospitalization) were reported in subjects who received AMEVIVE® [see ADVERSE REACTIONS]. AMEVIVE® should not be administered to patients with a clinically important infection. Exercise caution when considering the use of AMEVIVE® in patients with chronic infections or a history of recurrent infection. Patients should be monitored for signs and symptoms of infection during or after a course of AMEVIVE®. New infections should be closely monitored. If a patient develops a serious infection, AMEVIVE® should be discontinued [see ADVERSE REACTIONS]. Concomitant Therapies Patients receiving other immunosuppressive agents or phototherapy should not receive concurrent therapy with AMEVIVE® because of the possibility of excessive immunosuppression. Immunizations The safety and efficacy of live or live-attenuated vaccines in patients being treated with AMEVIVE® have not been studied. In a study of 46 patients with chronic plaque psoriasis, the ability to mount immunity to tetanus toxoid (recall antigen) and an experimental neo-antigen was preserved in those patients undergoing AMEVIVE® therapy. Hypersensitivity Reactions Urticaria and angioedema have been associated with the administration of AMEVIVE®. If an anaphylactic reaction or other serious allergic reaction occurs, discontinue AMEVIVE® immediately and initiate appropriate therapy. Hepatic Injury In post-marketing experience there have been reports of liver injury, including asymptomatic transaminase elevation, fatty infiltration of the liver, hepatitis, decompensation of cirrhosis with liver failure, and acute liver failure. Liver failure has been reported with concomitant alcohol use [see ADVERSE REACTIONS]. In the 24-week period constituting the first course of placebo-controlled studies, 1.7% (15/876) of AMEVIVE®-treated patients and 1.2% (5/413) of the placebo group experienced ALT and/or AST elevations of at least 3 times the upper limit of normal. While the exact relationship of these occurrences with the use of AMEVIVE®has not been established, patients with signs or symptoms of liver injury should be fully evaluated. AMEVIVE® should be discontinued in patients who develop clinical signs of liver injury. Patient Counseling Information "See FDA-approved patient labeling (Medication Guide)" Inform patients of the need for regular monitoring of white blood cell (lymphocyte) counts during therapy with AMEVIVE®. Inform patients that the reduction in lymphocytes could increase their chances of developing an infection or a malignancy. Advise patients to inform their physician promptly if they develop any signs of an infection or malignancy while undergoing a course of treatment with AMEVIVE®. Advise female patients to notify their physicians if they become pregnant while taking AMEVIVE® or within 8 weeks of discontinuing AMEVIVE®. Inform patients that serious liver injury has been reported in patients receiving AMEVIVE®. Patients should be advised to report to their physician persistent nausea, anorexia, fatigue, vomiting, abdominal pain, jaundice, easy bruising, dark urine or pale stools. Inform patients that hypersensitivity reactions have been reported in patients receiving AMEVIVE®. Patients should promptly notify their physicians should urticaria or signs of angioedema (e.g. facial edema) develop. Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment of Fertility In a chronic toxicity study, cynomolgus monkeys were dosed weekly for 52 weeks with intravenous alefacept at 1 mg/kg/dose or 20 mg/kg/dose. One animal in the high dose group developed a B-cell lymphoma that was detected after 28 weeks of dosing. Additional animals in both dose groups developed B-cell hyperplasia of the spleen and lymph nodes. One-year post-treatment there was no evidence of alefacept-related lymphoma or B-cell hyperplasia in any of the remaining treated monkeys. All animals in the study were positive for an endemic primate gammaherpes virus also known as lymphocryptovirus (LCV). Latent LCV infection is generally asymptomatic, but can lead to B-cell lymphomas when animals are immune suppressed. In a separate study, baboons given 3 doses of alefacept at 1 mg/kg every 8 weeks were found to have centroblast proliferation in B-cell dependent areas in the germinal centers of the spleen following a 116-day washout period. The role of AMEVIVE® in the development of the lymphoid malignancy and the hyperplasia observed in non-human primates and the relevance to humans is unknown. Immunodeficiency-associated lymphocyte disorders (plasmacytic hyperplasia, polymorphic proliferation, and B-cell lymphomas) occur in patients who have congenital or acquired immunodeficiencies including those resulting from immunosuppressive therapy. No formal carcinogenicity or fertility studies were conducted. Mutagenicity studies were conducted in vitro and in vivo; no evidence of mutagenicity was observed. Use In Specific Populations Pregnancy Pregnancy Category B There are no adequate and well-controlled studies of AMEVIVE® in pregnant women. AMEVIVE® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Reproductive toxicology studies have been performed in cynomolgus monkeys at doses up to 5 mg/kg/week (about 62 times the human dose based on body weight) and have revealed no evidence of impaired fertility or harm to the fetus due to AMEVIVE®. No abortifacient or teratogenic effects were observed in cynomolgus monkeys following intravenous bolus injections of AMEVIVE® administered weekly during the period of organogenesis to gestation. AMEVIVE® underwent trans-placental passage and produced in utero exposure in the developing monkeys. In utero, serum levels of exposure in these monkeys were 23% of maternal serum levels. No evidence of fetal toxicity including adverse effects on immune system development was observed in any of these animals. Nursing Mothers It is not known whether AMEVIVE® is excreted in human milk. Because many drugs are excreted in human milk, and because there exists the potential for serious adverse reactions in nursing infants from AMEVIVE®, a decision should be made whether to discontinue nursing while taking the drug or to discontinue the use of the drug, taking into account the importance of the drug to the mother. Pediatric Use The safety and efficacy of AMEVIVE® in pediatric patients have not been studied. AMEVIVE® is not indicated for pediatric patients. Geriatric Use Of the 1869 patients who received AMEVIVE® in clinical trials, a total of 129 patients were ≥ 65 years of age and 16 patients were ≥ 75 years of age. No differences in safety or efficacy were observed between older and younger patients, but there were not sufficient data to exclude important differences. Because the incidence of infections and certain malignancies is higher in the elderly population, in general, caution should be used in treating the elderly. Last reviewed on RxList: 6/8/2012
This monograph has been modified to include the generic and brand name in many instances.
This monograph has been modified to include the generic and brand name in many instances.
Source: http://www.rxlist.com
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