Keytruda Lenvima Sticky

KEYTRUDA® IMPORTANT SAFETY INFORMATION

Clinical use:

The safety and efficacy of KEYTRUDA® has not been established for pediatric patients with conditions other than melanoma (Stage IIB, IIC, or III), relapsed or refractory cHL, or relapsed or refractory PMBCL, or unresectable or metastatic MSI-H or dMMR solid tumours.

Geriatrics (≥65 years of age): No overall differences in safety or efficacy were reported between elderly patients (65 years and over) and younger patients (less than 65 years) for KEYTRUDA® monotherapy . No overall differences in efficacy were reported between elderly patients (65 years and over) and younger patients (less than 65 years) for KEYTRUDA® combination therapy. Limited safety and efficacy information is available for KEYTRUDA® in cHL ≥ 65 years of age (n=20).

Relevant warnings and precautions:

• Immune-mediated adverse reactions, including severe and fatal cases:

• Pneumonitis
• Colitis
• Hepatitis
• Nephritis and renal dysfunction
• Endocrinopathies including adrenal insufficiency, hypophysitis, type 1 diabetes mellitus, and thyroid disorders
• Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis

• Other immune-mediated adverse events including uveitis, arthritis, myositis, encephalitis, sarcoidosis, myasthenic syndrome/myasthenia gravis, vasculitis, Guillain-Barré syndrome,
  hemolytic anemia, pancreatitis, myelitis, hypoparathyroidism, gastritis, pericarditis, myocarditis, sclerosing cholangitis, aplastic anemia, and exocrine pancreatic insufficiency
• Solid organ transplant rejection
• Use in combination with axitinib for RCC
• Allogeneic stem cell transplant after and before treatment
• Severe infusion-related reactions
• Teratogenic toxicity
• Women of childbearing potential should use highly effective contraception and take active measures to avoid pregnancy during treatment and for at least 4 months after the last dose
• Advise women not to breastfeed during treatment and for at least 4 months after the last dose
• Patients with hepatic impairment
• Renal impairment
• Driving and operating machinery
• Monitoring requirements
• Pediatrics
• Geriatrics

For more information:

Consult the KEYTRUDA® Product Monograph for important information regarding adverse reactions, drug interactions, and dosing information which have not been discussed in this piece. The Product Monograph is also available by calling us at 1-800-567-2594 or by email at medinfocanada@merck.com.

LENVIMA® IMPORTANT SAFETY INFORMATION

LENVIMA® (lenvatinib capsules) is indicated:

• In combination with pembrolizumab for the treatment of adult patients with advanced (not amenable to curative surgery or radiation) or metastatic RCC with no prior systemic therapy for metastatic RCC
• In combination with pembrolizumab for the treatment of adult patients with advanced EC that is not MSI-H or dMMR, who have disease progression following prior platinum-based systemic therapy, and are not candidates for curative surgery or radiation

Clinical use:

The safety and efficacy of LENVIMA® have not been established in patients <18 years of age.
In patients ≥65 years of age, adverse events Grade 3 or higher and discontinuations were higher than in patients <65 years of age.

Most serious warnings & precautions:

Hypertension and its complications, including fatal artery dissection

Cardiac failure, including fatal cases

Arterial thromboembolism (ATE), including fatal cases

Gastrointestinal perforation and fistula formation

Hepatic/biliary/pancreatic: Hepatotoxicity/hepatic failure, including fatal cases

Renal: Renal failure and impairment, including fatal cases

Hematologic: Hemorrhage, including fatal cases

Neurologic: Posterior reversible encephalopathy syndrome (PRES)

Other relevant warnings and precautions:

• Prior anticancer treatments
• QT interval prolongation; correct electrolyte abnormalities in all patients. Avoid use with electrolyte-disrupting drugs
• Hypocalcemia
• Impairment of thyroid stimulating hormone suppression/thyroid dysfunction
• Diarrhea: Initiate prompt medical management
• Osteonecrosis of the jaw (ONJ): Consider a dental examination and preventative dentistry prior to initiating LENVIMA®. If possible, avoid invasive dental procedures. Caution is advised with agents associated with ONJ, such as bisphosphonates and denosumab
• Wound healing complications
• Proteinuria
• Fertility
• Men and women of reproductive potential should use contraception
• Pregnancy: LENVIMA® should not be used during pregnancy unless necessary and based on a benefit/risk assessment of the mother and fetus
• Breastfeeding: LENVIMA® should not be used during breastfeeding
• Not recommended for patients with end-stage renal disease
• Monitoring and laboratory tests
• When LENVIMA® is used in combination with pembrolizumab, see the pembrolizumab Product Monograph

For more information:

Please consult the LENVIMA® Product Monograph for important information relating to adverse reactions, drug interactions, and dosing information that has not been discussed in this piece. The Product Monograph is also available by calling Eisai Limited at 1-877-873-4724.

cHL=classical Hodgkin lymphoma; dMMR=mismatch repair deficiency; MSI-H=microsatellite instability high; PMBCL=primary mediastinal large B-cell lymphoma; RCC=renal cell carcinoma.