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roe la' pi tant[Posted 01/16/2018] AUDIENCE: Pharmacy, Oncology, Nursing ISSUE: Anaphylaxis, anaphylactic shock and other serious hypersensitivity reactions have been reported in the postmarketing setting, some requiring hospitalization. These reactions have occurred during or soon after the infusion of rolapitant injectable emulsion. Most reactions have occurred within the first few minutes of administration. Symptoms of anaphylaxis can include wheezing or difficulty breathing; swelling of the face or throat; hives or flushing; itching; abdominal cramping, abdominal pain or vomiting; back pain or chest pain; hypotension or shock. See the Health Care Provider Letter, available at: http://bit.ly/2mDISBr, for important prescribing information to reflect the new safety information. BACKGROUND: Rolapitant injectable emulsion is approved to prevent delayed phase chemotherapy-induced nausea and vomiting (emesis). Rolapitant is approved in adults in combination with other drugs (antiemetic agents) that prevent nausea and vomiting associated with initial and repeat courses of vomit-inducing (emetogenic and highly emetogenic) cancer chemotherapy. RECOMMENDATION: Healthcare professionals must be vigilant for signs of hypersensitivity or anaphylaxis in all patients receiving rolapitant injectable emulsion, both during and following its administration. It is advised that Healthcare professionals consult with patients to determine if the patient is hypersensitive to any component of the product (including soybean oil). Furthermore, as cross reactions to other allergens is possible, patients with known allergies to legumes or other related allergens should be monitored closely. Patients with a potential hypersensitivity should not be administered rolapitant injectable emulsion. Appropriate treatment should be available for immediate use in the event of an anaphylactic reaction during treatment with rolapitant injectable emulsion. If anaphylaxis or any other serious hypersensitivity/infusion reaction occurs,
- administration of rolapitant injectable emulsion should be stopped immediately.
- appropriate medical management (including epinephrine and or antihistamines) should be initiated, and
- Rolapitant injectable emulsion should be permanently discontinued.
Before taking rolapitant,
- tell your doctor and pharmacist if you are allergic to rolapitant, any other medications, or any of the ingredients in rolapitant tablets. Ask your pharmacist for a list of the ingredients.
- tell your doctor if you are taking thioridazine. Your doctor will probably tell you not to take thioridazine if you are taking this medication.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: digoxin (Lanoxin), irinotecan (Camptosar), methotrexate (Otrexup, Rasuvo, Trexall), pimozide (Orap), rifampin (Rifadin, Rimactane, in Rifamate, in Rifater), rosuvastatin (Crestor), and topotecan (Hycamtin). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with rolapitant, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
- tell your doctor if you have or have ever had liver disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking rolapitant, call your doctor.
- stomach pain
- decreased appetite
- mouth sores