Treanda Patient Counseling Information

Allergic (Hypersensitivity) Reactions: Inform patients of the possibility of mild or serious allergic reactions and to immediately report rash, facial swelling, or difficulty breathing during or soon after infusion (see Precautions).
Myelosuppression: Inform patients of the likelihood that TREANDA will cause a decrease in white blood cells, platelets, and red blood cells, and the need for frequent monitoring of blood counts. Advise patients to report shortness of breath, significant fatigue, bleeding, fever, or other signs of infection (see Precautions).
Progressive Multifocal Leukoencephalopathy (PML): Inform patients to immediately contact their healthcare provider if they experience confusion, memory loss, trouble thinking, difficulty talking or walking, vision loss or other neurological or cognitive symptoms (see Precautions).
Hepatotoxicity: Inform patients of the possibility of developing liver function abnormalities and serious hepatic toxicity. Advise patients to immediately contact their health care provider if signs of liver failure occur, including jaundice, anorexia, bleeding or bruising (see Precautions).
Fatigue: Advise patients that TREANDA may cause tiredness and to avoid driving any vehicle or operating any dangerous tools or machinery if they experience this side effect (see Adverse Reactions).
Nausea and Vomiting: Advise patients that TREANDA may cause nausea and/or vomiting. Patients should report nausea and vomiting so that symptomatic treatment may be provided (see Adverse Reactions).
Diarrhea: Advise patients that TREANDA may cause diarrhea. Patients should report diarrhea to the physician so that symptomatic treatment may be provided (see Adverse Reactions).
Rash: Advise patients that a rash or itching may occur during treatment with TREANDA. Advise patients to immediately report severe or worsening rash or itching (see Precautions).
Non-Melanoma Skin Cancer (NMSC): Advise patients to undergo regular skin cancer screenings, and to report any suspicious skin changes to their healthcare provider (see Precautions).
Embryo-Fetal Toxicity: Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy (see Precautions, Use in Pregnancy & Lactation, and Pharmacology: Nonclinical Toxicology under Actions). Advise female patients of reproductive potential to use effective contraception during treatment with TREANDA and for at least 6 months after the final dose (see Use in Pregnancy & Lactation). Advise males with female partners of reproductive potential to use effective contraception during treatment with TREANDA and for at least 3 months after the final dose (see Use in Pregnancy & Lactation, and Pharmacology: Nonclinical Toxicology under Actions).
Lactation: Advise females not to breastfeed during treatment with TREANDA and for at least 1 week after the final dose (see Use in Pregnancy & Lactation).
Infertility: Advise males of reproductive potential that TREANDA may impair fertility (see Use in Pregnancy & Lactation).