MYLOTARG™ 17. PATIENT COUNSELING INFORMATION

(gemtuzumab ozogamicin)

17. PATIENT COUNSELING INFORMATION

Hepatotoxicity, Including Veno-occlusive Liver Disease (VOD)

Inform patients that liver problems, including severe, life-threatening, or fatal VOD may develop during MYLOTARG treatment. Prior to receiving MYLOTARG, inform patients who previously received, or will receive an HSCT that they may be at increased risk for developing VOD. Inform patients that the risk of developing VOD after an allogeneic HSCT is increased after receiving treatment with MYLOTARG. Inform patients that signs or symptoms of liver toxicity, including rapid weight gain, right upper quadrant pain and tenderness, hepatomegaly, and ascites should be monitored regularly during treatment, but these symptoms may not identify all patients at risk or prevent the complications of liver toxicity. Inform patients that liver problems may require dosing interruption or permanent discontinuation of MYLOTARG [see Warnings and Precautions (5.1)].

Hemorrhage

Inform patients that decreased platelet counts, which may be life-threatening, may develop during MYLOTARG treatment and that complications associated with decreased platelet counts may include bleeding/hemorrhage events, which may be life-threatening or fatal. Inform patients to report signs and symptoms of bleeding/hemorrhage during treatment with MYLOTARG. Inform patients that severe bleeding/hemorrhage may require dosing interruption or permanent discontinuation of MYLOTARG [see Warnings and Precautions (5.3)].

Infusion-Related Reactions

Advise patients to contact their health care provider if they experience signs and symptoms of infusion-related reactions, including symptoms such as fever, chills, rash, or breathing problems [see Warnings and Precautions (5.2)].

Embryo-Fetal Toxicity

Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.6), Use in Specific Populations (8.1)].

Advise females of reproductive potential to use effective contraception during treatment with MYLOTARG and for at least 6 months after the last dose [see Use in Specific Populations (8.3)].

Advise males with female partners of reproductive potential to use effective contraception during treatment with MYLOTARG and for at least 3 months after the last dose [see Use in Specific Populations (8.3)].

Lactation

Advise women not to breastfeed during treatment with MYLOTARG and for at least 1 month after the final dose [see Use in Specific Populations (8.2)].

Infertility

Advise males and females of reproductive potential that MYLOTARG may impair fertility [see Use in Specific Populations (8.3)].

Find MYLOTARG™ medical information:

Find MYLOTARG™ medical information:

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

MYLOTARG™ Quick Finder

Medication Guide

Health Professional Information

17. PATIENT COUNSELING INFORMATION

17. PATIENT COUNSELING INFORMATION

Hepatotoxicity, Including Veno-occlusive Liver Disease (VOD)

Inform patients that liver problems, including severe, life-threatening, or fatal VOD may develop during MYLOTARG treatment. Prior to receiving MYLOTARG, inform patients who previously received, or will receive an HSCT that they may be at increased risk for developing VOD. Inform patients that the risk of developing VOD after an allogeneic HSCT is increased after receiving treatment with MYLOTARG. Inform patients that signs or symptoms of liver toxicity, including rapid weight gain, right upper quadrant pain and tenderness, hepatomegaly, and ascites should be monitored regularly during treatment, but these symptoms may not identify all patients at risk or prevent the complications of liver toxicity. Inform patients that liver problems may require dosing interruption or permanent discontinuation of MYLOTARG [see Warnings and Precautions (5.1)].

Hemorrhage

Inform patients that decreased platelet counts, which may be life-threatening, may develop during MYLOTARG treatment and that complications associated with decreased platelet counts may include bleeding/hemorrhage events, which may be life-threatening or fatal. Inform patients to report signs and symptoms of bleeding/hemorrhage during treatment with MYLOTARG. Inform patients that severe bleeding/hemorrhage may require dosing interruption or permanent discontinuation of MYLOTARG [see Warnings and Precautions (5.3)].

Infusion-Related Reactions

Advise patients to contact their health care provider if they experience signs and symptoms of infusion-related reactions, including symptoms such as fever, chills, rash, or breathing problems [see Warnings and Precautions (5.2)].

Embryo-Fetal Toxicity

Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.6), Use in Specific Populations (8.1)].

Advise females of reproductive potential to use effective contraception during treatment with MYLOTARG and for at least 6 months after the last dose [see Use in Specific Populations (8.3)].

Advise males with female partners of reproductive potential to use effective contraception during treatment with MYLOTARG and for at least 3 months after the last dose [see Use in Specific Populations (8.3)].

Lactation

Advise women not to breastfeed during treatment with MYLOTARG and for at least 1 month after the final dose [see Use in Specific Populations (8.2)].

Infertility

Advise males and females of reproductive potential that MYLOTARG may impair fertility [see Use in Specific Populations (8.3)].

Prescribing Information
Download Prescribing Information

Health Professional Information

17. PATIENT COUNSELING INFORMATION

17. PATIENT COUNSELING INFORMATION

Hepatotoxicity, Including Veno-occlusive Liver Disease (VOD)

Inform patients that liver problems, including severe, life-threatening, or fatal VOD may develop during MYLOTARG treatment. Prior to receiving MYLOTARG, inform patients who previously received, or will receive an HSCT that they may be at increased risk for developing VOD. Inform patients that the risk of developing VOD after an allogeneic HSCT is increased after receiving treatment with MYLOTARG. Inform patients that signs or symptoms of liver toxicity, including rapid weight gain, right upper quadrant pain and tenderness, hepatomegaly, and ascites should be monitored regularly during treatment, but these symptoms may not identify all patients at risk or prevent the complications of liver toxicity. Inform patients that liver problems may require dosing interruption or permanent discontinuation of MYLOTARG [see Warnings and Precautions (5.1)].

Hemorrhage

Inform patients that decreased platelet counts, which may be life-threatening, may develop during MYLOTARG treatment and that complications associated with decreased platelet counts may include bleeding/hemorrhage events, which may be life-threatening or fatal. Inform patients to report signs and symptoms of bleeding/hemorrhage during treatment with MYLOTARG. Inform patients that severe bleeding/hemorrhage may require dosing interruption or permanent discontinuation of MYLOTARG [see Warnings and Precautions (5.3)].

Infusion-Related Reactions

Advise patients to contact their health care provider if they experience signs and symptoms of infusion-related reactions, including symptoms such as fever, chills, rash, or breathing problems [see Warnings and Precautions (5.2)].

Embryo-Fetal Toxicity

Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.6), Use in Specific Populations (8.1)].

Advise females of reproductive potential to use effective contraception during treatment with MYLOTARG and for at least 6 months after the last dose [see Use in Specific Populations (8.3)].

Advise males with female partners of reproductive potential to use effective contraception during treatment with MYLOTARG and for at least 3 months after the last dose [see Use in Specific Populations (8.3)].

Lactation

Advise women not to breastfeed during treatment with MYLOTARG and for at least 1 month after the final dose [see Use in Specific Populations (8.2)].

Infertility

Advise males and females of reproductive potential that MYLOTARG may impair fertility [see Use in Specific Populations (8.3)].

Resources

Didn’t find what you were looking for? Contact us.

MI Digital Assistant

Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine.

Call 800-438-1985*

*Contact Medical Information.9AM-5PM ET Monday to Friday; excluding holidays.

Report Adverse Event

Pfizer Safety

To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.

If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or call (800) 822-7967.