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More Energy.
More
Strength.
With forzinity
FORZINITY: The first and only medicine to improve muscle strength in Barth syndrome
FORZINITY is a once-daily injection indicated to improve muscle strength in individuals weighing at least 30 kg (~66 lbs) who are affected by Barth syndrome.
Repair the powerhouse of cells with FORZINITY
Forzinity is Designed to:
Improve muscle strength over time
Directly target the cardiolipin within mitochondria to help the body make energy more efficiently
Fit into daily life with once-a-day dosing
FORZINITY: The first and only medicine to improve muscle strength in Barth syndrome
FORZINITY is a once-daily injection indicated to improve muscle strength in individuals weighing at least 30 kg (~66 lbs) who are affected by Barth syndrome.
Repair the powerhouse of cells with FORZINITY
Forzinity is Designed to:
Improve muscle strength over time
Directly target the cardiolipin within mitochondria to help the body make energy more efficiently
Fit into daily life with once-a-day dosing
The controlled phase lasted 28 weeks
Twelve people participated in and finished this part of the study
The long-term extension lasted over 3 years
Ten people participated in and eight people finished this part of the study
Because Barth syndrome is so rare—only affecting about 200–250 individuals worldwide—the 12 people studied represent a meaningful portion of the Barth syndrome community.
The people studied were individuals affected by Barth syndrome
The average age was 19.5 years old
The average height was about
5 ft 6 in
The average weight was about 112 lbs
All study participants were male
In the TAZPOWER study, knee muscle strength was assessed
People taking FORZINITY showed more strength in their thigh muscles (the muscles that help straighten the knee) with continued treatment.
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How did FORZINITY help individuals like you or your loved one?
FORZINITY gave individuals with Barth syndrome more strength with continued treatment
After about 3 years of treatment, strength in the knee muscles improved by
Over
%
The FORZINITY indication was approved under accelerated approval based on an improvement in knee extensor muscle strength, an intermediate clinical endpoint. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Tracking progress matters
When starting FORZINITY, it's important to monitor progress, note any changes in symptoms, and have frequent check-ins with your doctor.
It's common to not see changes in symptoms right away with FORZINITY, so don’t get discouraged.
It may take at least a few months of treatment to see noticeable improvements.
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What are the most common side effects of FORZINITY?
FORZINITY side effects were usually mild to moderate, and they generally didn’t disrupt daily life for most people.
TAZPOWER Trial
FORZINITY
(12 participants total)
Placebo
(12 participants total)
Any reaction where injection was given
12 (100%)
8 (67%)
Redness
12 (100%)
3 (25%)
Hard or raised skin
8 (67%)
2 (17%)
Itching
8 (67%)
2 (17%)
Pain
9 (75%)
5 (42%)
Bruising
3 (25%)
0
Hives
3 (25%)
0
Bleeding
0
1 (8%)
If you have redness, swelling, or itching at your injection site, your doctor may recommend an antihistamine to help manage it.
Proper injection technique (such as rotating injection sites) is important and can help lessen the risk of reactions at your injection site.
Being prepared for reactions at your injection site can help you or your loved one feel more comfortable and confident throughout treatment.
Download the FORZINITY Care Guide to learn helpful strategies for managing these reactions.
Learn more about how to correctly inject your FORZINITY medication.
How do I take FORZINITY?What is FORZINITY®used for?
FORZINITY is a prescription medicine used to improve muscle strength in adult and pediatric individuals living with Barth syndrome weighing at least 30 kg. The safety and effectiveness of FORZINITY have not been established in pediatric individuals weighing less than 30 kg.
The recommended dosage of FORZINITY in most affected individuals weighing at least 30 kg is 40 mg subcutaneously once daily. For individuals with reduced renal function, please have your doctor refer to the Prescribing Information.
This indication is approved under accelerated approval based on an improvement in knee extensor muscle strength, an intermediate clinical endpoint. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
The risk information provided here is not comprehensive. To learn more, talk with your doctor and read the full Prescribing Information.
What should I tell my doctor before taking FORZINITY?
Before taking FORZINITY tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. You should also tell your doctor if you have or had:
- any allergies
- kidney problems
What are the possible side effects of FORZINITY?
- Injection site reactions: The most common side-effects or adverse reactions with FORZINITY are redness, swelling, pain, itching, bruising, or hives at the site of injection. These adverse reactions are referred to as injection site reactions.
- Allergic reactions. FORZINITY may cause allergic reactions, such as rash, small, raised skin bumps known as papular lesions, inflammation of the skin or eczematous dermatitis, as well as respiratory symptoms including cough. Stop using FORZINITY and get medical help right away if you develop any of the following symptoms of a severe allergic reaction:
-
- swelling of your face, lips, mouth, or tongue
- trouble breathing or airway constriction
- wheezing
- dizziness or fainting
- fast heartbeat or pounding in your chest
- sweating
These are NOT all of the possible side effects of FORZINITY.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.