essential [10:<60 bpm), increased heart rate (48%; 100 bpm), altered blood pressure (systolic 160 mmHg: 33%; systolic> <90 mmHg: 29%; diastolic 100 mmHg: 17%) Central nervous system: Fatigue (62%), peripheral neuropathy (27%; grades 3/4: 4%), headache (15%) Endocrine & metabolic: Hyperglycemia (89%), hypocalcemia (78%), hypoalbuminemia (73%), decreased serum bicarbonate (63%), hyperkalemia (32%), weight loss (14%) Gastrointestinal: Diarrhea (47%), constipation (36%), decreased appetite (21%), vomiting (15%) Hematologic & oncologic: Lymphocytopenia (13% to 99%; grades 3/4: 9% to 77%), leukopenia (91%; grades 3/4: 32%), thrombocytopenia (84%; grades 3/4: 19%) Hepatic: Increased serum alkaline phosphatase (39%; grades 3/4: 1%) Immunologic: Immunogenicity (19%; neutralizing: 6%) Infection: Infection (81%; grades 3/4: 28%), opportunistic infection (22%), herpes zoster (14%), fungal infection (10%) Neuromuscular & skeletal: Limb pain (16%) Ophthalmic: Cataract (12%) Respiratory: Cough (34%), nasopharyngitis (25%), upper respiratory tract infection (23%), pneumonia (15% to 20%), oropharyngeal pain (10%) Miscellaneous: Fever (7% to 37%), infusion related reaction (10%; grade 3: 1%) 1% to 10%: Cardiovascular: Chest pain ( 5%), pulmonary embolism (3%) Central nervous system: Hypoesthesia ( 5%), mood changes ( 5%) Dermatologic: Night sweats ( 5%) Hematologic & oncologic: Second primary malignant neoplasm (9%), malignant neoplasm of skin (4%), solid tumor (4%), anemia (3%), malignant neoplasm (hematologic: 2%) Hepatic: Hepatotoxicity (3%) Hypersensitivity: Hypersensitivity ( 5%) Renal: Acute renal failure (3%) Respiratory: Respiratory tract infection (3%) Warnings/Precautions Concerns related to adverse effects: Hepatotoxicity: Liver enzyme elevations (AST/ALT more than 3 times ULN, total bilirubin more than 2 times ULN, and alkaline phosphatase less than 2 times ULN) have occurred. Monitor liver function tests periodically; may require treatment interruption and/or discontinuation. Infection: Infections were reported in the majority of multiple myeloma patients treated in the clinical trial, including fatal infections. Monitor for opportunistic, fungal, herpes zoster, and other infections during therapy; treat promptly if infections occur. Infusion reactions: Infusion reactions (eg, fever, chills, hypertension) have been reported; all reactions were grade 3 or lower. Bradycardia and hypotension have also occurred during infusion. The majority of infusion reactions (~70%) occurred during the first dose. Premedicate with dexamethasone, H 1 - and H 2 -blockers, and acetaminophen prior to each dose. Administer in a facility with immediate access to resuscitative measures (eg, glucocorticoids, epinephrine, bronchodilators, and/or oxygen). May require treatment interruption, infusion rate modification, and/or discontinuation. Secondary malignancy: Invasive second primary malignancies have been reported. The rate of hematologic malignancies was the same between the elotuzumab/lenalidomide/dexamethasone group versus the lenalidomide/dexamethasone group. Solid tumors and skin cancer were reported more frequently in the elotuzumab arm versus the control group. Monitor for the development of secondary malignancies. Disease-related concerns: Interference with determination of myeloma response: Elotuzumab (a human IgG kappa monoclonal antibody) may be detected on serum protein electrophoresis and immunofixation assays which monitor for endogenous M-protein. Interference with these assays by elotuzumab may affect the determination of complete response and disease progression in some patients with IgG kappa myeloma protein. Concurrent drug therapy issues: Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Dosage form specific issues: Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling. Monitoring Parameters Liver function tests (periodically); signs/symptoms of infusion reactions (monitor vital signs every 30 minutes during and for 2 hours after the end of the infusion in patients who experience an infusion reaction), infections, and second primary malignancies Pregnancy Considerations Animal reproduction studies have not been conducted. Elotuzumab is indicated for use in combination with lenalidomide. Due to its potential to cause fetal harm, lenalidomide is only available through a REMS program. Males and females of reproductive potential using this combination must be able to comply with pregnancy testing and contraception requirements for lenalidomide. Refer to the lenalidomide monograph for additional information. Patient Education Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?) Patient may experience loss of strength and energy, diarrhea, constipation, burning or numbness feeling, rhinitis, pharyngitis, lack of appetite, painful extremities, vomiting, or weight loss. Have patient report immediately to prescriber signs of infection, signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), signs of high potassium (abnormal heartbeat, confusion, dizziness, passing out, weakness, shortness of breath, or numbness or tingling feeling), severe headache, dizziness, passing out, tachycardia, bradycardia, mole changes, skin growth, vision changes, angina, mood changes, night sweats, bruising, or bleeding (HCAHPS). Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions. Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients. Next Interactions Print this page Add to My Med List More about elotuzumab Side Effects During Pregnancy Dosage Information Drug Interactions Support Group En Español 0 Reviews Add your own review/rating Drug class: miscellaneous antineoplastics Consumer resources Elotuzumab Elotuzumab Intravenous (Advanced Reading) Professional resources Elotuzumab (AHFS Monograph) Other brands: Empliciti Related treatment guides Multiple Myeloma> ] Drug Status Rx Availability Prescription only N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Elotuzumab Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! Drug Class Miscellaneous antineoplastics Related Drugs miscellaneous antineoplastics tretinoin , Revlimid , Zytiga , Accutane , isotretinoin , irinotecan Multiple Myeloma dexamethasone , Decadron , Revlimid , cyclophosphamide , Cytoxan , Adriamycin , doxorubicin , Velcade , Doxil , vincristine , lenalidomide , Pomalyst , thalidomide , bortezomib , carfilzomib , Ninlaro , Kyprolis , melphalan , daratumumab , Thalomid , Dexasone , pomalidomide , carmustine , ixazomib , More... dedicated
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