Elotuzumab

Adverse reaction percentages listed are for all grades of toxicity unless otherwise stated

>10%

Heart rate <60 bpm (66%)

Fatigue (61.1%)

Heart rate ≥100 bpm (47.8%)

Diarrhea (46.9%)

Pyrexia (37.4%)

Cough (34.3%)

Systolic blood pressure ≥160 mmHg (33.3%)

Systolic blood pressure <90 mmHg (28.9%)

Infections, grades 3-4 (28%)

Peripheral neuropathy (26.7%)

Nasopharyngitis (24.5%)

Upper respiratory tract infection (22.6%)

Opportunistic infections, all (22%)

Decreased appetite (20.8%)

Pneumonia (20.1%)

Diastolic blood pressure ≥100 mmHg (17.3%)

Pain in extremities (16.4%)

Headache (15.4%)

Vomiting (14.5%)

Pneumonia, grades 3-4 (14.2%)

Decreased weight (13.8%)

Herpes zoster infections (13.5%)

Lymphopenia (13.2%)

Fatigue, grades 3-4 (12.6%)

Cataracts (11.9%)

Oropharyngeal pain (10.1%)

1-10%

Infusion related reactions (10%)

Fungal infections (9.7%)

Secondary primary malignancies (9.1%)

Lymphopenia, grades 3-4 (8.8%)

Cataracts, grades 3-4 (6.3%)

Diarrhea, grades 3-4 (5%)

Peripheral neuropathy, grades 3-4 (3.8%)

Pyrexia, grades 3-4 (2.5%)

Hepatotoxicity (2.5%)

Constipation, grades 3-4 (1.3%)

Decreased weight, grades 3-4 (1.3%)

Infusion reactions, grade 3 (1%)

Contraindications

None for elotuzumab

See lenalidomide and dexamethasone prescribing information

Cautions

Infusion reactions can occur and may include fever, chills, and hypertension (see Dosage Modifications)

Infections reported, including opportunistic infections (eg, fungal infections, herpes zoster)

Second primary malignancies reported, including solid tumors and skin cancers

Elevations in liver enzymes (AST/ALT >3 x ULN, TB >2 x ULN, and alkaline phosphatase <2 x ULN) consistent with hepatotoxicity were reported; monitor liver enzymes periodically; stop elotuzumab for ≥grade 3 elevation of liver enzymes; may consider treatment continuation after return to baseline values

Humanized IgG kappa monoclonal antibody that can be detected on both the serum protein electrophoresis (SPEP) and immunofixation (IFE) assays used for the clinical monitoring of endogenous M-protein; this interference can impact the determination of complete response and possibly relapse from complete response in patients with IgG kappa myeloma protein

Elotuzumab is a prescription medication used, with two other medications, to treat multiple myeloma, type of blood cancer. It is given to patients who have received one to three prior therapies. 

It belongs to a group of drugs called monoclonal antibodies. These work by helping certain cells in the immune system attack cancer cells.

This medication is available as a solution that is injected into the vein (IV) by a healthcare professional. It is typically given once a week for the first two cycles and every two weeks, thereafter. 

Common side effects of elotuzumab include pneumonia, fever, and respiratory tract infection. 

Elotuzumab is a monoclonal antibody that blocks a certain protein in the body that can affect tumor cell growth. Monoclonal antibodies are made to target and destroy only certain cells in the body. This may help to protect healthy cells from damage.

Elotuzumab is used in combination chemotherapy to treat multiple myeloma (bone marrow cancer). Elotuzumab is given together with lenalidomide and a steroid medicine called dexamethasone.

Lenalidomide (Revlimid) is available only under a special program. You must be registered in the program and understand the risks and benefits of taking this medicine.

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

Elotuzumab is given in combination with other drugs. You may be given medicine to prevent certain side effects while you are receiving elotuzumab. Use all medications as directed by your doctor. Read all patient information, medication guides, and instruction sheets provided to you. Do not change your doses or medication schedule without your doctor's advice.

Elotuzumab is injected into a vein through an IV. A healthcare provider will give you this injection. This medicine must be injected slowly, and the IV infusion can take at least 30 minutes to complete.

Your combination chemotherapy will be given in a 28-day treatment cycle. Elotuzumab is usually given once per week. Your doctor will determine how long to treat you with elotuzumab.

You may need to take your other medications daily. Follow all directions on your prescription label. Do not take your medicines in larger or smaller amounts or for longer than recommended.

Elotuzumab can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using elotuzumab.

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 the injection. Tell your caregiver right away if you feel dizzy, itchy, chilled, feverish, light-headed, or short of breath.

Call your doctor at once if you have:

• fever, chills, flu-like symptoms;

• pain or burning when you urinate;

• severe skin rash;

• liver problems--loss of appetite, upper stomach pain, tiredness, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• signs of pneumonia--cough with yellow or green mucus, stabbing chest pain, wheezing, feeling short of breath.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

• fever, cough, tiredness;

• numbness, tingling, or burning pain in your arms or legs;

• loss of appetite;

• diarrhea, constipation; or

• cold symptoms such as runny nose or sore throat.

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.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as an infusion into a vein over a period of time.
• Other drugs may be given to help with infusion side effects.

What do I do if I miss a dose?

• Call your doctor to find out what to do.
• If you miss a dose of the steroid drug (dexamethasone) or if it is stopped, talk with your doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling tired or weak.
• Loose stools (diarrhea).
• Hard stools (constipation).
• A burning, numbness, or tingling feeling that is not normal.
• Nose or throat irritation.
• Not hungry.
• Pain in arms or legs.
• Headache.
• Throwing up.
• Weight loss.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Body weight: Clearance increases with increasing body weight.

CrCl ≤89 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling; however, based on pharmacokinetics, dosage adjustment is not likely necessary.

Elotuzumab may be detected on both serum protein electrophoresis (SPEP) and serum immunofixation assays used for multiple myeloma endogenous M-protein monitoring, and may affect the determination of complete response and disease progression of some patients with IgG kappa myeloma protein. A small peak in the early gamma region on SPEP that is IgG kappa on serum immunofixation may potentially be attributed to elotuzumab (especially when endogenous myeloma protein is IgA, IgM, IgD, or lambda light chain restricted).

All incidences reported in combination with lenalidomide and dexamethasone.

>10%:

Cardiovascular: Decreased heart rate (66%; <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%)

Animal studies have not been conducted with this drug. There are no controlled data in human pregnancy. AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

This drug should be used during pregnancy only if the benefit outweighs the risk. AU TGA pregnancy category: C US FDA pregnancy category: Not assigned Comments: -The effects in the developing fetus are unknown. -This drug is administered in combination with lenalidomide and dexamethasone. Lenalidomide can cause embryofetal harm and is contraindicated for use in pregnancy. Refer to the lenalidomide and dexamethasone prescribing information for additional information. -Male patients should use effective contraception during and for 6 months following treatment if their partner is pregnant or of childbearing potential and not using effective contraception.