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Columvi

Columvi Patient Counseling Information

Manufacturer:

Roche

Distributor:

DKSH
Full Prescribing Info
Patient Counseling Information
Advise the patient to read the Medication Guide.
Cytokine Release Syndrome: Inform patients of the risk of CRS. Advise patients to seek immediate medical attention if they experience signs and symptoms of CRS (fever, hypoxia, hypotension, chills and tachycardia) [see Precautions].
Provide patients with the Patient Wallet Card that they should carry with them at all times. This card describes symptoms of CRS which, if experienced, should prompt the patient to seek immediate medical attention.
Neurologic Toxicity: Discuss the signs and symptoms associated with neurologic toxicity, including ICANS, headache, peripheral neuropathy, dizziness, or mental status changes. Advise patients to immediately contact their healthcare provider if they experience any signs or symptoms of neurologic toxicity. Advise patients who experience neurologic toxicity that impairs consciousness to refrain from driving or operating heavy or potentially dangerous machinery until neurologic toxicity resolves [see Precautions].
Serious Infections: Advise patients that COLUMVI can cause serious infections. Advise patients to notify their healthcare provider immediately if they develop any signs of infection (e.g., fever, chills, weakness) [see Precautions].
Tumor Flare: Inform patients of the potential risk of tumor flare reaction and to report any signs and symptoms associated with this event (e.g., localized pain and swelling) to their healthcare provider for evaluation [see Precautions].
Embryo-Fetal Toxicity: Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider if they are pregnant or become pregnant. Advise females of reproductive potential to use effective contraception during treatment with COLUMVI and for 1 month after the last dose [see Precautions and Use in Pregnancy & Lactation].
Advise women not to breastfeed while receiving treatment with COLUMVI and for 1 month after the last dose [see Use in Pregnancy & Lactation].
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