Medical Editor: John P. Cunha, DO, FACOEP
What Is Bafiertam?
Bafiertam (monomethyl fumarate) is a selective immunosuppressant indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
What Are Side Effects of Bafiertam?
Side effects of Bafiertam include:
- flushing,
- abdominal pain,
- diarrhea,
- nausea,
- vomiting,
- itching,
- rash,
- albumin in urine,
- redness, and
- indigestion/heartburn
Dosage for Bafiertam
The starting dose of Bafiertam is 95 mg twice a day, orally, for 7 days. The maintenance dose of Bafiertam after 7 days is 190 mg (administered as two 95 mg capsules) twice a day, orally.
Bafiertam In Children
Safety and effectiveness of Bafiertam in pediatric patients have not been established.
What Drugs, Substances, or Supplements Interact with Bafiertam?
Bafiertam may interact with other medicines such as:
- dimethyl fumarate or diroximel fumarate
Tell your doctor all medications and supplements you use.
Bafiertam During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Bafiertam; it may harm a fetus. It is unknown if Bafiertam passes into breast milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Bafiertam and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition.
Additional Information
Our Bafiertam (monomethyl fumarate) Delayed-Release Capsules, for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
QUESTION
What kind of disease is multiple sclerosis? See AnswerGet emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Monomethyl fumarate may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement. These symptoms may start gradually and get worse quickly.
Also call your doctor at once if you have:
- severe warmth, redness, burning, or itching under your skin;
- liver problems--loss of appetite, stomach pain (upper right side), tiredness, dark urine, jaundice (yellowing of the skin or eyes);
- signs of infection --fever, chills, sweating, mouth sores, headache, confusion, neck stiffness, sensitivity to light, vomiting, severe diarrhea; or
- symptoms of herpes virus--flu-like symptoms, cold sores around your mouth, tingly or painful blistering rash, burning pain in your thigh or lower back.
Common side effects may include:
- flushing (sudden warmth, redness, or tingly feeling);
- stomach pain, indigestion;
- nausea, vomiting; or
- diarrhea.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Bafiertam (Monomethyl Fumarate Delayed-release Capsules)
SLIDESHOW
What Is Multiple Sclerosis? MS Symptoms, Causes, Diagnosis See SlideshowSIDE EFFECTS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Anaphylaxis and Angioedema [see WARNINGS AND PRECAUTIONS].
- Progressive Multifocal Leukoencephalopathy [see WARNINGS AND PRECAUTIONS].
- Herpes Zoster and Other Serious Opportunistic Infections [see WARNINGS AND PRECAUTIONS].
- Lymphopenia [see WARNINGS AND PRECAUTIONS].
- Liver Injury [see WARNINGS AND PRECAUTIONS].
- Flushing [see WARNINGS AND PRECAUTIONS].
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described in the following sections were obtained using dimethyl fumarate delayed-release capsules (the prodrug of BAFIERTAM).
Adverse Reactions In Placebo-Controlled Trials With Dimethyl Fumarate
In the two well-controlled studies demonstrating effectiveness, 1529 patients received dimethyl fumarate with an overall exposure of 2244 person-years [see Clinical Studies].
The adverse reactions presented in Table 1 below are based on safety information from 769 patients treated with dimethyl fumarate 240 mg twice a day and 771 placebo-treated patients. The most common adverse reactions (incidence ≥10% and ≥2% more than placebo) for dimethyl fumarate were flushing, abdominal pain, diarrhea, and nausea.
Table 1: Adverse Reactions in Study 1 and 2 Reported for Dimethyl Fumarate at ≥ 2% Higher Incidence than Placebo
| Adverse Reaction | Dimethyl Fumarate 240 mg Twice Daily | Placebo |
| N=769 % | N=771 % | |
| Flushing | 40 | 6 |
| Abdominal pain | 18 | 10 |
| Diarrhea | 14 | 11 |
| Nausea | 12 | 9 |
| Vomiting | 9 | 5 |
| Pruritus | 8 | 4 |
| Rash | 8 | 3 |
| Albumin urine present | 6 | 4 |
| Erythema | 5 | 1 |
| Dyspepsia | 5 | 3 |
| Aspartate aminotransferase increased | 4 | 2 |
| Lymphopenia | 2 | <1 |
Gastrointestinal
Dimethyl fumarate caused GI events (e.g., nausea, vomiting, diarrhea, abdominal pain, and dyspepsia). In clinical trials, the incidence of GI events was higher early in the course of treatment (primarily during the first month) and usually decreased over time in patients treated with dimethyl fumarate compared with placebo. Four percent (4%) of patients treated with dimethyl fumarate and less than 1% of patients on placebo discontinued due to gastrointestinal events. The incidence of serious GI events was 1% in patients treated with dimethyl fumarate.
Hepatic Transaminases
An increased incidence of elevations of hepatic transaminases in patients treated with dimethyl fumarate in clinical trials was seen primarily during the first six months of treatment, and most patients with elevations had levels < 3 times the upper limit of normal (ULN). Elevations of alanine aminotransferase and aspartate aminotransferase to ≥ 3 times the ULN occurred in a small number of patients treated with both dimethyl fumarate and in patients on placebo, and were balanced between the groups. There were no elevations in transaminases ≥ 3 times the ULN with concomitant elevations in total bilirubin > 2 times the ULN. Discontinuations due to elevated hepatic transaminases were < 1%, and were similar in patients treated with dimethyl fumarate or placebo.
Eosinophilia
A transient increase in mean eosinophil counts was seen during the first 2 months of therapy with dimethyl fumarate.
Adverse Reactions In Studies With BAFIERTAM (Monomethyl Fumarate)
In clinical studies, a total of 178 healthy subjects have received single doses of BAFIERTAM. The adverse reaction profile of BAFIERTAM was consistent with the experience in the placebo-controlled clinical trials with dimethyl fumarate. Taking BAFIERTAM without food may reduce the incidence of GI events.
Postmarketing Experience
The following adverse reactions have been identified during post approval use of dimethyl fumarate (the prodrug of BAFIERTAM). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Liver function abnormalities (elevations in transaminases ≥ 3 times ULN with concomitant elevations in total bilirubin > 2 times ULN) have been reported following administration in postmarketing experience [see WARNINGS AND PRECAUTIONS].
Herpes zoster infection and other serious opportunistic infections have been reported following administration in postmarketing experience [see WARNINGS AND PRECAUTIONS].
Read the entire FDA prescribing information for Bafiertam (Monomethyl Fumarate Delayed-release Capsules)
© Bafiertam Patient Information is supplied by Cerner Multum, Inc. and Bafiertam Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.