FORZINITY- elamipretide hydrochloride injection
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Anum Ijaz M.B.B.S., M.D.[2]
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Overview
FORZINITY- elamipretide hydrochloride injection is a mitochondrial cardiolipin binder. that is FDA approved for the treatment of Barth syndrome in adult and pediatric patients weighing at least 30 kg, to improve muscle strength.. Common adverse reactions include injection site reactions..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Barth Syndrome
- FORZINITY is indicated to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kg.
- 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.
Dosing Information
- The recommended dosage of FORZINITY in patients weighing at least 30 kg is 40 mg subcutaneously once daily.
- Patients should receive the dose at the same time each day.
Missed Dose
- If a dose is missed, skip the dose and take the next dose of FORZINITY at the scheduled time. Do not take a double dose of FORZINITY.
Dosage Modifications For Renal Impairment
- Refer to the Table for dosage modifications in adults with renal impairment.
| Estimated Glomerular Filtration Rate (eGFR) (mL/minute) | Recommended Dosage |
|---|---|
| Greater than or equal to 30 mL/minute | 40 mg subcutaneously once daily |
| Less than 30 mL/minute and NOT on dialysis | 20 mg subcutaneously once daily |
- There is insufficient information to recommend a dosage regimen in adults with eGFR less than 30 mL/minute and on dialysis.
- There is insufficient information to recommend a dosage regimen in pediatric patients weighing 30 kg or greater with renal impairment.
Important Administration Instructions
- FORZINITY is a clear, colorless to yellow aqueous solution that contains the preservative, benzyl alcohol.
- Visually inspect each vial of FORZINITY for particulate matter and cloudiness prior to administration, whenever solution and container permit.
- Do not use if the solution is cloudy or particulate matter is present.
- Adult patients or caregivers may administer FORZINITY after proper training in preparing FORZINITY vials for administration, if a healthcare provider determines that it is appropriate, and with medical follow-up as necessary.
- Use aseptic technique to prepare and administer FORZINITY.
- Administer FORZINITY by subcutaneous injection in the abdomen (at least 2 inches from the navel) or outer thigh and rotate the injection site daily.
- Do not inject where the skin is tender, bruised, red, or hard.
- Avoid injecting into scars or stretch marks.
- Refer to the Instructions for Use for preparation and administration.
- FORZINITY is for single-patient-use only.
- Do not mix other products in the same syringe.
- Discard vials 8 days after first opening.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of FORZINITY- elamipretide hydrochloride injection in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of FORZINITY- elamipretide hydrochloride injection in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FORZINITY- elamipretide hydrochloride injection FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of FORZINITY- elamipretide hydrochloride injection in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of FORZINITY- elamipretide hydrochloride injection in pediatric patients.
Contraindications
- Serious hypersensitivity to elamipretide or any of the excipients in FORZINITY.
Warnings
Risk of Benzyl Alcohol Toxicity in Neonates
- FORZINITY is not approved for use in neonates.
- Serious adverse reactions, including fatal reactions, of new onset or worsening metabolic acidosis that progressed to neurotoxicity, and in some cases gasping syndrome, have been reported in low-birth weight neonates (less than 2,500 grams) and preterm neonates (gestational age less than 34 weeks) who received benzyl alcohol (BA)-containing drugs intravenously.
- FORZINITY is not approved for intravenous use.
- Gasping syndrome is a life-threatening condition in neonates caused by BA toxicity and is primarily characterized by multiorgan dysfunction secondary to metabolic acidosis, which leads to gasping respirations and death.
- The minimum amount of BA at which these serious adverse reactions, including fatal reactions, may occur is not known (FORZINITY contains 20 mg of BA per mL).
Hypersensitivity
- Hypersensitivity reactions, including serious allergic reactions requiring emergency medical intervention, have been reported in patients receiving FORZINITY.
- These reactions have included skin manifestations such as rash, papular lesions, and eczematous dermatitis, as well as respiratory symptoms including cough.
- Reactions may occur within minutes to months after treatment initiation.
- Monitor patients for signs and symptoms of hypersensitivity reactions during treatment.
- If a serious hypersensitivity reaction occurs, do not administer further doses of FORZINITY and institute appropriate emergency treatment, including epinephrine, antihistamines, and corticosteroids as clinically indicated.
- Patients who have experienced a serious hypersensitivity reaction should not be rechallenged with FORZINITY.
- For mild to moderate skin reactions, consider treatment with topical corticosteroids and oral antihistamines.
- Consider discontinuation of FORZINITY if persistent or severe skin reactions develop.
Adverse Reactions
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.
- In the FORZINITY clinical development program, 12 male patients aged 12 to 35 years with genetically-confirmed Barth syndrome received treatment with daily subcutaneous injections of 40 mg FORZINITY.
- Eleven of these 12 patients were Caucasian.
- Patients first participated in a double-blind, placebo-controlled crossover trial where they were randomized to one of two sequences: 12 weeks of FORZINITY in Period 1 then a 4-week washout followed by 12 weeks of placebo in Period 2 or 12 weeks of placebo in Period 1 then a 4-week washout followed by 12 weeks of FORZINITY in Period 2.
- Ten patients completed the randomized trial and entered the open-label extension period where they received FORZINITY once daily.
- Eight of these patients received FORZINITY for 168 weeks, three of whom received FORZINITY for a total of 192 weeks.
- Adverse reactions occurring more commonly on FORZINITY than on placebo include injection site reactions such as injection site erythema, pain, induration, pruritus, bruising, and urticaria.
Eosinophilia: Increases in absolute eosinophil counts were noted frequently in studies where duration of administration of FORZINITY was 30 days or greater. Eosinophil counts generally peaked around 90 days after initial exposure (mean increase from baseline ~0.5 to 0.6 × 103/uL) and returned to baseline levels after 6 to 12 months of continuous exposure or after discontinuation of FORZINITY. The elevation in eosinophils was not associated with clinical manifestations or changes in other laboratory parameters.
Summary of Adverse Drug Reactions in the Placebo-Controlled Crossover Study, Barth Safety Population
| Adverse Reaction | Combined (Periods 1 and 2) Elamipretide N=12 n (%) | Combined (Periods 1 and 2) Placebo N=12 n (%) |
|---|---|---|
| Any local administration reaction | 12 (100) | 8 (67) |
| Injection site erythema | 12 (100) | 3 (25) |
| Injection site induration | 8 (67) | 2 (17) |
| Injection site pruritus | 8 (67) | 2 (17) |
| Injection site pain | 9 (75) | 5 (42) |
| Injection site bruising | 3 (25) | 0 |
| Injection site urticaria | 3 (25) | 0 |
| Injection site hemorrhage | 0 | 1 (8) |
Postmarketing Experience
There is limited information regarding FORZINITY- elamipretide hydrochloride injection Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding FORZINITY- elamipretide hydrochloride injection Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA): Risk Summary
- Barth Syndrome is a rare, X-linked, recessive, genetic disorder and is not likely to affect females.
- Therefore, there are no data with FORZINITY use in pregnant women to evaluate for a drug-related risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.
- In animal reproduction studies, no adverse developmental outcomes occurred at any dose tested (see Data).
- FORZINITY contains benzyl alcohol as a preservative.
- Because benzyl alcohol is rapidly metabolized by a pregnant woman, benzyl alcohol exposure in the fetus is unlikely.
- The background risk of major birth defects and miscarriage for the indicated population is unknown.
- All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
- In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of FORZINITY- elamipretide hydrochloride injection in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of FORZINITY- elamipretide hydrochloride injection during labor and delivery.
Nursing Mothers
Risk Summary
- Barth Syndrome is a rare, X-linked, recessive, genetic disorder and is not likely to affect females.
- Therefore, there is no data to evaluate the presence of FORZINITY in human milk, the effect on the breastfed infant, or the effects on milk production.
- FORZINITY contains benzyl alcohol.
- Because benzyl alcohol is rapidly metabolized by a lactating female, benzyl alcohol exposure in the breastfed infant is unlikely.
- The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for FORZINITY and any potential adverse effects on the breastfed infant from FORZINITY or from the underlying maternal condition.
Pediatric Use
- The safety and effectiveness of FORZINITY to improve muscle strength have been established in pediatric patients with Barth syndrome weighing at least 30 kg.
- Use of FORZINITY for this indication is supported by improvement in knee extensor muscle strength, an intermediate clinical endpoint, observed in an open-label extension study of FORZINITY that included seven pediatric patients aged 12 years and older.
- The safety and effectiveness of FORZINITY have not been established in pediatric patients weighing less than 30 kg.
- FORZINITY is not approved for use in neonates.
- Serious adverse reactions, including fatal reactions, of new onset or worsening metabolic acidosis that progressed to neurotoxicity, and in some cases gasping syndrome, have been reported in low-birth weight neonates and preterm neonates who received BA containing drugs intravenously (FORZINITY is not approved for intravenous use).
- Gasping syndrome is a life-threatening condition in neonates caused by BA toxicity that is characterized by new onset or worsening metabolic acidosis with gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and gasping respirations followed by death.
- In reported cases, BA in amounts of 99 to 234 mg/kg/day produced blood BA levels of 6.6 to 14.9 mg/dL, but the minimum amount of BA at which gasping syndrome may occur in neonates is not known (FORZINITY contains 20 mg of BA per mL).
Geriatic Use
There is no FDA guidance on the use of FORZINITY- elamipretide hydrochloride injection in geriatric settings.
Gender
There is no FDA guidance on the use of FORZINITY- elamipretide hydrochloride injection with respect to specific gender populations.
Race
There is no FDA guidance on the use of FORZINITY- elamipretide hydrochloride injection with respect to specific racial populations.
Renal Impairment
Renal Impairment
- No dosage adjustment is required for patients with mild (eGFR 60 to 89 mL/min) or moderate (eGFR 30 to 59 mL/min) renal impairment.
- The FORZINITY dose should be reduced by one half administered subcutaneously once daily in adults with severe renal impairment (eGFR less than 30 mL/min) who are not on dialysis.
- FORZINITY has not been studied in patients with renal failure on dialysis.
Dosage Modifications For Renal Impairment
- Refer to Table 1 for dosage modifications in adults with renal impairment.
| Estimated Glomerular Filtration Rate (eGFR) (mL/minute) | Recommended Dosage |
|---|---|
| Greater than or equal to 30 mL/minute | 40 mg subcutaneously once daily |
| Less than 30 mL/minute and NOT on dialysis | 20 mg subcutaneously once daily |
- There is insufficient information to recommend a dosage regimen in adults with eGFR less than 30 mL/minute and on dialysis.
- There is insufficient information to recommend a dosage regimen in pediatric patients weighing 30 kg or greater with renal impairment.
Hepatic Impairment
Specific Populations (Clinical Pharmacology)
- No hepatic metabolism was observed for elamipretide in vitro.
- Hepatic impairment is not expected to alter the pharmacokinetics (PK) of elamipretide.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of FORZINITY- elamipretide hydrochloride injection in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of FORZINITY- elamipretide hydrochloride injection in patients who are immunocompromised.
Administration and Monitoring
Administration
- FORZINITY is a clear, colorless to yellow aqueous solution that contains the preservative, benzyl alcohol.
- Visually inspect each vial of FORZINITY for particulate matter and cloudiness prior to administration, whenever solution and container permit.
- Do not use if the solution is cloudy or particulate matter is present.
- Adult patients or caregivers may administer FORZINITY after proper training in preparing FORZINITY vials for administration, if a healthcare provider determines that it is appropriate, and with medical follow-up as necessary.
- Use aseptic technique to prepare and administer FORZINITY.
- Administer FORZINITY by subcutaneous injection in the abdomen (at least 2 inches from the navel) or outer thigh and rotate the injection site daily.
- Do not inject where the skin is tender, bruised, red, or hard.
- Avoid injecting into scars or stretch marks.
- Refer to the Instructions for Use for preparation and administration.
- FORZINITY is for single-patient-use only.
- Do not mix other products in the same syringe.
- Discard vials 8 days after first opening.
Monitoring
Hypersensitivity
- Monitor patients for signs and symptoms of hypersensitivity reactions during treatment.
- If a serious hypersensitivity reaction occurs, do not administer further doses of FORZINITY and institute appropriate emergency treatment, including epinephrine, antihistamines, and corticosteroids as clinically indicated.
- Patients who have experienced a serious hypersensitivity reaction should not be rechallenged with FORZINITY.
- For mild to moderate skin reactions, consider treatment with topical corticosteroids and oral antihistamines.
- Consider discontinuation of FORZINITY if persistent or severe skin reactions develop.
IV Compatibility
There is limited information regarding the compatibility of FORZINITY- elamipretide hydrochloride injection and IV administrations.
Overdosage
There is limited information regarding FORZINITY- elamipretide hydrochloride injection overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding FORZINITY- elamipretide hydrochloride injection Pharmacology in the drug label.
Mechanism of Action
FORZINITY is a mitochondrial cardiolipin binder that localizes to the inner mitochondrial membrane and improves mitochondrial morphology and function.
Structure
- FORZINITY contains elamipretide, a mitochondrial cardiolipin binder.
- Elamipretide is isolated as a hydrochloride salt that is freely soluble in water.
- The chemical name for elamipretide hydrochloride is L-Phenylalaninamide, D-arginyl-2,6-dimethyl-L-tyrosyl-L-lysyl-, hydrochloride (1:3).
- Its molecular formula is C32H49N9O5∙3HCl and its molecular weight is 749.2.
- All amino acid residues in FORZINITY have the L configuration except for arginine which has the D configuration.
- The peptide sequence is denoted as D-Arg-2,6-dimethyl-Tyr-Lys-Phe-NH2.
- FORZINITY is a ready-to-use sterile, clear, colorless to yellow aqueous solution supplied as single-patient-use vials containing 3.5 mL solution for subcutaneous injection.
- Each 0.5 mL dose of FORZINITY contains 40 mg of elamipretide (equivalent to 46.8 mg elamipretide hydrochloride), 10 mg benzyl alcohol as a preservative, and 2.07 mg monobasic sodium phosphate (as monohydrate).
- The product may contain hydrochloric acid or sodium hydroxide to adjust pH.
- The pH of FORZINITY solution is 4.7 to 6.1.
Pharmacodynamics
Effects on QTc Interval
Cardiac electrophysiology
- Clinically significant QTc interval prolongation was not observed at 3 times the peak concentration of the maximum recommended FORZINITY dose.
Pharmacokinetics
Absorption
- Elamipretide exposure increases proportionally over a dose range of 2 to 80 mg following daily subcutaneous injections with minimal accumulation.
- Maximum elamipretide concentrations were reached between 0.5 to 1 hour after subcutaneous administration.
- The absolute bioavailability following subcutaneous administration is approximately 92%.
- FORZINITY exposure is comparable after subcutaneous injection to the thigh or to the abdomen.
Distribution
- Elamipretide is distributed throughout total body water with an approximate volume of distribution of 0.5 L/kg.
- There is low binding to plasma proteins (approximately 39%).
Elimination
Metabolism
- Elamipretide is metabolized via sequential C-terminal degradation to the M1 tripeptide and M2 dipeptide metabolites, which do not have pharmacological activity.
Excretion
- Elamipretide and its metabolites M1 and M2 are excreted in the urine.
- At 48 hours post-dose, approximately 100% of the FORZINITY dose was recovered in the urine as either elamipretide, M1, or M2 in patients with normal renal function.
Specific Populations
- Elamipretide exposure (AUC) increased by 39% in subjects with creatinine clearance 60 to 89 mL/min, 75% in subjects with creatinine clearance 30 to 59 mL/min, and 125% in subjects with creatinine clearance less than 30 mL/min not on dialysis.
- Renal impairment was categorized based on 24-hour measured urinary creatinine clearance.
- There was minimal accumulation of elamipretide with daily dosing, regardless of the severity of renal impairment.
- There was a significant increase in exposure of the M1 and M2 metabolites, up to 280% and 640%, respectively, in subjects with severe renal impairment not on dialysis (creatinine clearance less than 30 mL/min).
- While the effect of renal impairment on elamipretide pharmacokinetics was characterized using 24-hour measured urinary creatinine clearance, analyses conducted with estimated glomerular filtration (CKD-EPI equation) support the recommendations for use in this specific population.
- No hepatic metabolism was observed for elamipretide in vitro.
- Hepatic impairment is not expected to alter the pharmacokinetics (PK) of elamipretide.
Drug Interaction Studies
In Vitro Studies
- Elamipretide does not inhibit CYP1A, CYP2D6, CYP2E1, CYP2B6, CYP2C8, CYP2C9, CYP2C19, or CYP3A.
- Elamipretide does not induce metabolism by CYP1A2, CYP2B6, or CYP3A4.
- Elamipretide does not inhibit the activity of OCT2, BCRP, OAT1, OAT3, OATP1B1, OATP1B3, P-gp, or MATE2-K.
- Elamipretide is an inhibitor of MATE1 (IC50 3.53 μM).
In Vivo Clinical Studies
- Administration of elamipretide (0.1 mg/kg/hour for 4 hours via intravenous infusion) starting 4 hours after a single dose of 650 mg aspirin did not affect the PK of aspirin and its metabolite, salicylic acid.
- There was no impact on the antiplatelet activity of aspirin when co-administered with elamipretide.
- Administration of elamipretide (0.1 mg/kg/hour for 4 hours via intravenous infusion) starting 4 hours after a single dose of 300 mg clopidogrel did not significantly affect the PK of clopidogrel.
- There was no impact on the anti-thrombotic activity of clopidogrel when co-administered with elamipretide.
- Administration of elamipretide (0.25 mg/kg/hour for 4 hours via intravenous infusion) had no significant impact on activated partial thromboplastin time (aPTT) and anti-factor Xa activity of unfractionated heparin, when co-administered 7 hours after starting the unfractionated heparin infusion.
Nonclinical Toxicology
Carcinogenesis, Mutagenesis, Impairment of Fertility
- Carcinogenicity studies have not been conducted with elamipretide.
- Elamipretide was negative in an in vitro bacterial reverse mutation assay, a chromosomal aberration assay in Chinese hamster ovary cells, and an in vivo rat bone marrow micronucleus assay.
- Subcutaneous doses of elamipretide in rats of up to 20 mg/kg/day, approximately 5-times the clinical exposure at the MRHD of 40 mg, did not adversely affect fertility or reproductive performance.
Clinical Studies
- FORZINITY was evaluated in a randomized, double-blind, placebo-controlled, crossover trial and its 192-week, open-label, single-arm extension period.
- The randomized trial evaluated the efficacy and safety of once daily FORZINITY 40 mg injected subcutaneously for 12 weeks in 12 subjects ≥12-years-old and >30 kg with genetically confirmed Barth syndrome.
- The primary endpoints for the randomized trial were distance walked during 6-minute walk test and Total Fatigue Score on the Barth syndrome Symptom Assessment.
- FORZINITY was not superior to placebo on these primary endpoints.
- Ten subjects completed the randomized trial and entered the extension period designed to evaluate long-term safety and tolerability of FORZINITY.
- Eight of these 10 subjects participated through Week 168 of the extension period.
- Knee extensor muscle strength measured by handheld dynamometry was evaluated as one of the secondary endpoints in the randomized trial and in the extension period.
- Increases in knee extensor muscle strength were not observed during the randomized trial but were observed during the extension period.
- At the pre-dose baseline visit at the start of the randomized trial, median (min, max) muscle strength was 124 (92, 176) newtons.
- Table 3 shows descriptive changes from pre-dose baseline for knee extensor muscle strength during the randomized controlled trial and extension period.
Descriptive Statistics, Changes from Baseline in Muscle Strength (newtons)
| Visit | N | Median Change | Min, Max Change |
|---|---|---|---|
| Randomized Controlled Trial | |||
| Week 12 Placebo | 12 | -5 | -31, 48 |
| Week 12 Elamipretide | 12 | 4 | -41, 86 |
| Open-Label Extension Period | |||
| Week 12 | 10 | 34 | 7, 95 |
| Week 24 | 9 | 68 | 3, 90 |
| Week 36 | 8 | 57 | 9, 92 |
| Week 48 | 8 | 41 | -2, 144 |
| Week 72 | 8 | 35 | -4, 100 |
| Week 168 | 8 | 63 | 38, 78 |
How Supplied
- FORZINITY (elamipretide) injection is a sterile, clear, colorless to yellow aqueous solution supplied as:
- Carton containing four 280 mg/3.5 mL (80 mg/mL) single-patient-use vials (NDC 72507-800-04)
Storage
- Store refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze.
- Following the first dose, the opened vial can be stored either refrigerated 2°C to 8°C (36°F to 46°F) or at room temperature between 20°C to 25°C (68°F to 77°F).
- Discard vials 8 days after first opening.
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Patient Counseling Information
Patient Counseling Information
- Advise the patient and caregiver to read the FDA-approved patient labeling (Instructions for Use).
- Instruct patients and caregivers to discard vials 8 days after first opening.
- Instruct patients and caregivers on how to prepare and administer the correct dose of FORZINITY using aseptic technique.
- Instruct patients and caregivers to administer FORZINITY by subcutaneous injection in the abdomen (at least 2 inches from the navel) or outer thigh and to rotate the injection site daily according to the Instructions for Use.
- Instruct patients and caregivers not to inject where the skin is tender, bruised, red, or hard and to avoid injecting into scars or stretch marks.
- Inform patients and caregivers that injection site reactions such as erythema, pain, induration, pruritus, bruising, or urticaria can be treated with antihistamines or topical corticosteroids.
- Advise the patient and caregiver to discontinue FORZINITY and seek immediate medical attention if any signs or symptoms of an immediate hypersensitivity reaction occur.
Instructions for Use
- This Instructions for Use contains information on how to inject FORZINITY.
- Read this Instructions for Use before you inject a dose of FORZINITY for the first time.
- This information does not take the place of talking to your healthcare provider about your medical condition or treatment. Ask your healthcare provider about any instructions you do not understand.
- Your or your child's healthcare provider will show you how to prepare and inject FORZINITY before you use the vial for the first time. It is recommended that FORZINITY injections be prepared and given by adults or adult caregivers.
- FORZINITY is for injection under the skin (subcutaneous injection).
- FORZINITY is injected 1 time each day, at the same time each day.
- If a dose of FORZINITY is missed, skip that dose, and take the next dose of FORZINITY at the next scheduled time. Do not double a dose of FORZINITY.
- FORZINITY vial contains enough medicine for more than 1 dose.
- Do not mix FORZINITY with other medicines in the same syringe.
Precautions with Alcohol
Alcohol-FORZINITY- elamipretide hydrochloride injection interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
Look-Alike Drug Names
There is limited information regarding FORZINITY- elamipretide hydrochloride injection Look-Alike Drug Names in the drug label.
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References
The contents of this FDA label are provided by the National Library of Medicine.