Cardiomyopathy [see Warnings and Precautions (5.2)] |
- •
- Asymptomatic, absolute decrease in LVEF of greater than 10% from baseline that is also below lower limit of normal (LLN)
| Withhold MEKTOVI for up to 4 weeks, evaluate LVEF every 2 weeks. Resume MEKTOVI at a reduced dose if the following are present: - •
- LVEF is at or above the lower limit of normal and
- •
- Absolute decrease from baseline is 10% or less and
- •
- Patient is asymptomatic.
If the LVEF does not recover within 4 weeks permanently discontinue MEKTOVI. |
- •
- Symptomatic congestive heart failure or absolute decrease in LVEF of greater than 20% from baseline that is also below LLN
| Permanently discontinue MEKTOVI. |
Venous Thromboembolism [see Warnings and Precautions (5.3)] |
- •
- Uncomplicated deep venous thrombosis (DVT) or pulmonary embolism (PE)
| Withhold MEKTOVI. - •
- If improves to Grade 0-1, resume at a reduced dose.
- •
- If no improvement, permanently discontinue MEKTOVI.
|
- •
- Life threatening PE
| Permanently discontinue MEKTOVI. |
Serous Retinopathy [see Warnings and Precautions (5.4)] |
- •
- Symptomatic serous retinopathy/Retinal pigment epithelial detachments
| Withhold MEKTOVI for up to 10 days. - •
- If improves and becomes asymptomatic, resume at same dose.
- •
- If not improved, resume at a lower dose level or permanently discontinue MEKTOVI.
|
Retinal Vein Occlusion (RVO) [see Warnings and Precautions (5.4)] |
- •
- Any Grade
| Permanently discontinue MEKTOVI. |
Uveitis [see Warnings and Precautions (5.4)] |
- •
- Grade 1-3
| If Grade 1 or 2 does not respond to specific ocular therapy, or for Grade 3 uveitis, withhold MEKTOVI for up to 6 weeks. - •
- If improved, resume at same or reduced dose.
- •
- If not improved, permanently discontinue MEKTOVI.
|
- •
- Grade 4
| Permanently discontinue MEKTOVI. |
Interstitial Lung Disease [see Warnings and Precautions (5.5)] |
- •
- Grade 2
| Withhold MEKTOVI for up to 4 weeks. - •
- If improved to Grade 0-1, resume at a reduced dose.
- •
- If not resolved within 4 weeks, permanently discontinue MEKTOVI.
|
- •
- Grade 3 or Grade 4
| Permanently discontinue MEKTOVI. |
Hepatotoxicity [see Warnings and Precautions (5.6)] |
- •
- Grade 2 AST or ALT increased
| Maintain MEKTOVI dose. - •
- If no improvement within 2 weeks, withhold MEKTOVI until improved to Grade 0-1 or to pretreatment/baseline levels and then resume at the same dose.
|
- •
- Grade 3 or 4 AST or ALT increased
| See Other Adverse Reactions. |
Rhabdomyolysis or Creatine Phosphokinase (CPK) elevations [see Warnings and Precautions (5.7)] |
- •
- Grade 4 asymptomatic CPK elevation or
- •
- Any Grade CPK elevation with symptoms or with renal impairment
| Withhold MEKTOVI dose for up to 4 weeks. - •
- If improved to Grade 0-1 resume at a reduced dose.
- •
- If not resolved within 4 weeks, permanently discontinue MEKTOVI.
|
Dermatologic [other than palmar plantar erythrodysesthesia syndrome (PPES)] [see Adverse Reactions (6.1)] |
- •
- Grade 2
| If no improvement within 2 weeks, withhold MEKTOVI until Grade 0-1. Resume at same dose if first occurrence or reduce dose if recurrent. |
- •
- Grade 3
| Withhold MEKTOVI until Grade 0-1. Resume at same dose if first occurrence or reduce dose if recurrent. |
- •
- Grade 4
| Permanently discontinue MEKTOVI. |
Other Adverse Reactions (including Hemorrhage) [see Warnings and Precautions (5.8), Adverse Reactions (6.1)]† |
- •
- Recurrent Grade 2 or
- •
- First occurrence of any Grade 3
| Withhold MEKTOVI for up to 4 weeks. - •
- If improves to Grade 0-1 or to pretreatment/baseline levels, resume at reduced dose.
- •
- If no improvement, permanently discontinue MEKTOVI.
|
- •
- First occurrence of any Grade 4
| Permanently discontinue MEKTOVI, or Withhold MEKTOVI for up to 4 weeks. - •
- If improves to Grade 0-1 or to pretreatment/baseline levels, then resume at a reduced dose.
- •
- If no improvement, permanently discontinue MEKTOVI.
|
- •
- Recurrent Grade 3
| Consider permanently discontinuing MEKTOVI. |
- •
- Recurrent Grade 4
| Permanently discontinue MEKTOVI. |