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Keytruda健痊得

Keytruda Patient Counseling Information

pembrolizumab

Manufacturer:

MSD

Distributor:

Zuellig
/
Agencia Lei Va Hong
Full Prescribing Info
Patient Counseling Information
Immune-Mediated Adverse Reactions: Inform patients of the risk of immune-mediated adverse reactions that may be severe or fatal, may occur after discontinuation of treatment, and may require corticosteroid treatment and interruption or discontinuation of KEYTRUDA. These reactions may include: Pneumonitis: Advise patients to contact their healthcare provider immediately for new or worsening cough, chest pain, or shortness of breath [see Immune-Mediated Pneumonitis under Precautions].
Colitis: Advise patients to contact their healthcare provider immediately for diarrhea or severe abdominal pain [see Immune-Mediated Colitis under Precautions].
Hepatitis: Advise patients to contact their healthcare provider immediately for jaundice, severe nausea or vomiting, or easy bruising or bleeding [see Immune-Mediated Hepatitis (KEYTRUDA) and Hepatotoxicity (KEYTRUDA in Combination with Axitinib): Immune-Mediated Hepatitis under Precautions].
Adrenal Insufficiency: Advise patients to contact their healthcare provider immediately for extreme weakness, dizziness, or fainting [see Immune-Mediated Endocrinopathies: Adrenal Insufficiency under Precautions].
Hypophysitis: Advise patients to contact their healthcare provider immediately for persistent or unusual headache, extreme weakness, dizziness or fainting, or vision changes [see Immune-Mediated Endocrinopathies: Hypophysitis under Precautions].
Hyperthyroidism and Hypothyroidism: Advise patients to contact their healthcare provider immediately for signs or symptoms of hyperthyroidism and hypothyroidism [see Immune-Mediated Endocrinopathies: Thyroid Disorders under Precautions].
Type 1 Diabetes Mellitus: Advise patients to contact their healthcare provider immediately for signs or symptoms of type 1 diabetes [see Immune-Mediated Endocrinopathies: Type 1 Diabetes mellitus under Precautions].
Nephritis: Advise patients to contact their healthcare provider immediately for signs or symptoms of nephritis [see Immune-Mediated Nephritis and Renal Dysfunction under Precautions].
Severe skin reactions: Advise patients to contact their healthcare provider immediately for any signs or symptoms of severe skin reactions, SJS or TEN [see Immune-Mediated Skin Adverse Reactions under Precautions].
Other immune-mediated adverse reactions: Advise patients that immune-mediated adverse reactions can occur and may involve any organ system, and to contact their healthcare provider immediately for any new signs or symptoms [see Other Immune-Mediated Adverse Reactions under Precautions].
Advise patients of the risk of solid organ transplant rejection and to contact their healthcare provider immediately for signs or symptoms of organ transplant rejection [see Other Immune-Mediated Adverse Reactions under Precautions].
Infusion-Related Reactions: Advise patients to contact their healthcare provider immediately for signs or symptoms of infusion-related reactions [see Infusion-Related Reactions under Precautions].
Complications of Allogeneic HSCT: Advise patients of the risk of post-allogeneic hematopoietic stem cell transplantation complications [see Complications of Allogeneic HSCT under Precautions].
Embryo-Fetal Toxicity: Advise females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider of a known or suspected pregnancy [see Embryo-Fetal Toxicity under Precautions; Pregnancy and Females and Males of Reproductive Potential under Use in Pregnancy & Lactation].
Advise females of reproductive potential to use effective contraception during treatment with KEYTRUDA and for 4 months after the last dose [see Embryo-Fetal Toxicity under Precautions; Pregnancy and Females and Males of Reproductive Potential under Use in Pregnancy & Lactation].
Lactation: Advise women not to breastfeed during treatment with KEYTRUDA and for 4 months after the final dose [see Lactation under Use in Pregnancy & Lactation].
Laboratory Tests: Advise patients of the importance of keeping scheduled appointments for blood work or other laboratory tests [see Immune-Mediated Hepatitis (KEYTRUDA) and Hepatotoxicity (KEYTRUDA in Combination with Axitinib), Immune-Mediated Endocrinopathies, and Immune-Mediated Nephritis and Renal Dysfunction under Precautions].
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