Braftovi

Question 1

Is BRAFTOVI safe to use during pregnancy?

Accepted Answer

No, BRAFTOVI can cause fetal harm when administered to a pregnant woman. There are no available clinical data on its use during pregnancy. Animal studies showed developmental changes and abortifacient effects at doses greater than those used clinically. Pregnant women or females of reproductive potential should be informed of the potential risk to the fetus.

Question 2

What is the recommendation for breastfeeding while using BRAFTOVI?

Accepted Answer

There are no data on the presence of BRAFTOVI in human milk. Due to potential serious adverse reactions in a breastfed child, women are advised not to breastfeed during BRAFTOVI treatment and for 2 weeks after the last dose.

Question 3

Does BRAFTOVI affect fertility in males?

Accepted Answer

In male rats, BRAFTOVI showed impacts on fertility at doses approximately 13 times the human exposure at the clinical dose. Males considering BRAFTOVI treatment should discuss potential impacts on fertility with their healthcare provider.

Question 4

Are there specific precautions for females of reproductive potential using BRAFTOVI?

Accepted Answer

Females of reproductive potential should undergo pregnancy testing before starting BRAFTOVI. Effective contraception is advised during treatment and for 2 weeks after the last dose. Non-hormonal contraception methods are recommended due to potential interactions.

Question 5

Has BRAFTOVI been studied in pediatric patients?

Accepted Answer

The safety and effectiveness of BRAFTOVI haven't been established in pediatric patients.

Question 6

What information is available regarding the use of BRAFTOVI in elderly patients?

Accepted Answer

Clinical studies included elderly patients (aged 65 and older) with BRAF mutation-positive melanoma, metastatic CRC, and NSCLC. No significant differences in safety or effectiveness were observed between older and younger patients.

Question 7

Are there recommended dosage adjustments for patients with hepatic impairment?

Accepted Answer

No dosage adjustment is recommended for patients with mild hepatic impairment. However, there's no established dosage for those with moderate or severe hepatic impairment.

Question 8

Is there a recommended BRAFTOVI dosage adjustment for patients with renal impairment?

Accepted Answer

No dosage adjustment is recommended for patients with mild to moderate renal impairment. There isn't a recommended dosage for those with severe renal impairment.