| Novantrone®: Descriptives1 |
| Method of administration |
Intravenous infusion |
| Indication |
For reducing neurologic disability and/or the frequency of clinical relapses in
patients with progressive relapsing, or worsening relapsing-remitting MS.
Not indicated for primary progressive MS |
| Needle size |
N/A |
| Delivery information |
Four times a year by IV infusion. Lifetime limit of 8-12 doses (12mg/m2 every 3 months) |
| Injection aid(s) |
N/A–must be administered at a medical facility |
| Pregnancy category |
Category D1 (can cause fetal harm when administered to a pregnant woman).2 Pregnancy tests results required before receiving each dose of Novantrone® |
| Black box warning |
Yes* |
*Summary of black box warning3:
Novantrone® can cause the following serious problems:
- Novantrone® may damage your heart at any time during treatment or months to years after treatment ends. Heart damage from Novantrone® can be serious and may cause death. Your chance of heart problems depends on the amount of Novantrone® you have used. Your doctor will limit your number of Novantrone® doses. Your doctor will do certain tests to see if your heart is normal:
- before you start Novantrone®
- before each dose of Novantrone®
- if you have symptoms of heart problems during and after treatment with Novantrone®
- Novantrone® can increase your chance of getting an infection
- Patients treated with Novantrone® have an increased chance of developing leukemia
| Novantrone®: Common side effects/reactions1 |
| Clinically significant difference in flu-like symptoms when compared to placebo (an inactive substance) |
No |
| Fatigue/Malaise (bodily discomfort) increased while on therapy |
No |
| Warning for use in people with depression |
No |
| Warning for use in people with suicidal thoughts |
No |
| Warning or precaution for liver impairment |
Yes |
| Recommended monitoring of liver function or complete blood count |
Yes |
| Associated with localized site reactions |
Yes |
| Associated with neutralizing antibodies (proteins produced by the body that may decrease the effectiveness of therapy) |
No |
Additional important information about Novantrone®3
Novantrone® can cause the following serious problems:
- Novantrone® may damage your heart at any time during treatment or months to years
after treatment ends. Heart damage from Novantrone® can be serious and may cause
death. Your chance of heart problems depends on the amount of Novantrone that you
have used. Your doctor will limit your number of Novantrone® doses. Your doctor will
do certain tests to see if your heart is normal:
- before you start Novantrone®
- before each dose of Novantrone®
- if you have symptoms of heart problems during and after treatment with Novantrone®
- Novantrone® can increase your chance of getting an infection
- Patients treated with Novantrone® have an increased chance of developing leukemia
- Novantrone® should not be used:
- by women who are pregnant or trying to get pregnant
- if your heart's ability to pump blood is decreased
- if you have a low number of white blood cells
- if you are allergic to Novantrone®
- Before taking Novantrone®, tell your doctor about your past and current health conditions including:
- heart disease
- cancer treatment
- radiation to the chest
- blood-clotting or bleeding problems, low blood counts, infections
- liver disease or problems
Tell your doctor about all the medicines you take. Tell your doctor if you ever
had treatment with Novantrone®.
The most common side effects of Novantrone® in patients
with MS are nausea, hair thinning, loss of menstrual periods, mouth sores, and bladder
infections.
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