Drug Detail:Elahere (Mirvetuximab soravtansine [ mir-ve-tux-i-mab-soe-rav-tan-seen ])
Drug Class: Miscellaneous antineoplastics
Highlights of Prescribing Information
ELAHERE™ (mirvetuximab soravtansine-gynx) injection, for intravenous use
Initial U.S. Approval: 2022
WARNING: OCULAR TOXICITY
See full prescribing information for complete boxed warning.
- ELAHERE can cause severe ocular toxicities, including visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis. (5.1, 6.1)
- Conduct an ophthalmic exam including visual acuity and slit lamp exam prior to initiation of ELAHERE, every other cycle for the first 8 cycles, and as clinically indicated. (2.3)
- Administer prophylactic artificial tears and ophthalmic topical steroids. (2.3, 5.1)
- Withhold ELAHERE for ocular toxicities until improvement and resume at the same or reduced dose. (2.4, 5.1)
- Discontinue ELAHERE for Grade 4 ocular toxicities. (2.4, 5.1)
Indications and Usage for Elahere Injection
ELAHERE is a folate receptor alpha (FRα)-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Select patients for therapy based on an FDA-approved test. (1, 2.1)
This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. (1, 14)
Elahere Injection Dosage and Administration
- Administer ELAHERE as an intravenous infusion only after dilution in 5% Dextrose Injection, USP. ELAHERE is incompatible with normal saline. (2.5)
- The recommended dose of ELAHERE is 6 mg/kg adjusted ideal body weight administered as an intravenous infusion every 3 weeks until disease progression or unacceptable toxicity. (2.2)
- Premedicate with a corticosteroid, antihistamine, and antipyretic. (2.3)
- Premedicate with an antiemetic, ophthalmic topical steroids, and lubricating eye drops. (2.3, 5.1)
- See full Prescribing Information for preparation and administration instructions and dose modifications for adverse reactions. (2)
Dosage Forms and Strengths
- Injection: 100 mg/20 mL (5 mg/mL) in a single-dose vial. (3)
Contraindications
- None. (4)
Warnings and Precautions
- Pneumonitis: Withhold ELAHERE for persistent or recurrent Grade 2 pneumonitis and consider dose reduction. Permanently discontinue ELAHERE for Grade 3 or 4 pneumonitis. (2.4, 5.2)
- Peripheral Neuropathy: Monitor patients for new or worsening peripheral neuropathy. Withhold dosage, dose reduce, or permanently discontinue ELAHERE based on the severity of peripheral neuropathy. (2.4, 5.3)
- Embryo-Fetal Toxicity: ELAHERE can cause fetal harm. Advise of the potential risk to a fetus and to use effective contraception. (5.4, 8.1, 8.3)
Adverse Reactions/Side Effects
The most common (≥20 %) adverse reactions, including laboratory abnormalities, were vision impairment, fatigue, increased aspartate aminotransferase, nausea, increased alanine aminotransferase, keratopathy, abdominal pain, decreased lymphocytes, peripheral neuropathy, diarrhea, decreased albumin, constipation, increased alkaline phosphatase, dry eye, decreased magnesium, decreased leukocytes, decreased neutrophils, and decreased hemoglobin. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact ImmunoGen at 1-833-486-4646 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug Interactions
Strong CYP3A4 Inhibitors: Closely monitor for ELAHERE adverse reactions. (7.1)
Use In Specific Populations
- Lactation: Advise not to breastfeed. (8.2)
- Moderate or severe hepatic impairment: Avoid use. (8.7)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 11/2022
Full Prescribing Information
WARNING: OCULAR TOXICITY
- ELAHERE can cause severe ocular toxicities, including visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)].
- Conduct an ophthalmic exam including visual acuity and slit lamp exam prior to initiation of ELAHERE, every other cycle for the first 8 cycles, and as clinically indicated [see Dosage and Administration (2.3)].
- Administer prophylactic artificial tears and ophthalmic topical steroids [see Dosage and Administration (2.3) and Warnings and Precautions (5.1)].
- Withhold ELAHERE for ocular toxicities until improvement and resume at the same or reduced dose [see Dosage and Administration (2.4) and Warnings and Precautions (5.1)].
- Discontinue ELAHERE for Grade 4 ocular toxicities [see Dosage and Administration (2.4) and Warnings and Precautions (5.1)].
1. Indications and Usage for Elahere Injection
ELAHERE™ is indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Select patients for therapy based on an FDA-approved test [see Dosage and Administration (2.1)].
This indication is approved under accelerated approval based on tumor response rate and durability of response [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
2. Elahere Injection Dosage and Administration
2.1 Patient Selection
Select patients for the treatment of platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer with ELAHERE based on the presence of FRα tumor expression [see Indications & Usage (1) and Clinical Studies (14)] using an FDA-approved test.
Information on FDA-approved tests for the measurement of FRα tumor expression is available at http://www.fda.gov/CompanionDiagnostics.
2.2 Recommended Dosage
The recommended dose of ELAHERE is 6 mg/kg adjusted ideal body weight (AIBW) administered once every 3 weeks (21-day cycle) as an intravenous infusion until disease progression or unacceptable toxicity [see Dosage and Administration (2.5)].
The total dose of ELAHERE is calculated based on each patient's AIBW using the following formula:
| AIBW = Ideal Body Weight (IBW [kg]) + 0.4*(Actual weight [kg] – IBW) | |
| Female IBW (kg) = 0.9*height(cm) – 92 |
2.4 Dosage Modifications
Table 2 provides dose reductions and modifications for adverse reactions. Adjust the schedule of administration to maintain a 3-week interval between doses.
| ELAHERE Dose Levels | |
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| Starting Dose | 6 mg/kg AIBW |
| First Dose Reduction | 5 mg/kg AIBW |
| Second Dose Reduction | 4 mg/kg AIBW* |
| Adverse Reaction | Severity of Adverse Reaction* | Dosage Modification |
|---|---|---|
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| Keratitis/Keratopathy
[see Warnings and Precautions (5.1) and Adverse Reactions (6.1)] | Nonconfluent superficial keratitis | Monitor. |
| Confluent superficial keratitis, a cornea epithelial defect, or 3-line or more loss in best corrected visual acuity | Withhold dose until improved or resolved, then maintain at same dose level or consider dose reduction. | |
| Corneal ulcer or stromal opacity or best corrected distance visual acuity 20/200 or worse | Withhold dose until improved or resolved, then reduce by one dose level. | |
| Corneal perforation | Permanently discontinue. | |
| Uveitis
[see Warnings and Precautions (5.1) and Adverse Reactions (6.1)] | Grade 1/ Rare cell in anterior chamber | Monitor. |
| Grade 2/ 1-2+ Cell or Flare in anterior chamber | Withhold dose until Grade 1 or less, then maintain dose at same dose level. | |
| Grade 3/ 3+ Cell or Flare in anterior chamber | Withhold dose until Grade 1 or less, then reduce dose by one dose level. | |
| Grade 4/ Hypopyon | Permanently discontinue. | |
| Pneumonitis
[see Warnings and Precautions (5.2) and Adverse Reactions (6.1)] | Grade 1 | Monitor. |
| Grade 2 | Withhold dose until Grade 1 or less, then resume at same dose level or one lower dose level at the discretion of the healthcare provider. | |
| Grade 3 or 4 | Permanently discontinue. | |
| Peripheral Neuropathy
[see Warnings and Precautions (5.3) and Adverse Reactions (6.1)] | Grade 2 | Withhold dose until Grade 1 or less, then reduce by one dose level. |
| Grade 3 or 4 | Permanently discontinue. | |
| Infusion-Related Reactions/Hypersensitivity
[see Adverse Reactions (6.1)] | Grade 1 | Maintain infusion rate. |
| Grade 2 |
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| Grade 3 or 4 |
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| Other Adverse Reactions
[see Adverse Reactions (6.1)] | Grade 3 | Withhold dose until Grade 1 or less, then resume at one lower dose level. |
| Grade 4 | Permanently discontinue. | |
3. Dosage Forms and Strengths
Injection: 100 mg/20 mL (5 mg/mL) clear to slightly opalescent, colorless solution in a single-dose vial.
5. Warnings and Precautions
5.1 Ocular Disorders
ELAHERE can cause severe ocular adverse reactions, including visual impairment, keratopathy (corneal disorders), dry eye, photophobia, eye pain, and uveitis.
Ocular adverse reactions occurred in 61% of patients with ovarian cancer treated with ELAHERE. Nine percent (9%) of patients experienced Grade 3 ocular adverse reactions, including visual impairment, keratopathy/keratitis (corneal disorders), dry eye, photophobia, and eye pain; and one patient (0.2%) experienced Grade 4 keratopathy. The most common (≥5%) ocular adverse reactions were visual impairment (49%), keratopathy (36%), dry eye (26%), cataract (15%), photophobia (13%), and eye pain (12%) [see Adverse Reactions (6.1)].
The median time to onset for first ocular adverse reaction was 1.2 months (range: 0.03 to 12.9). Of the patients who experienced ocular events, 49% had complete resolution and 39% had partial improvement (defined as a decrease in severity by one or more grades from the worst grade) at last follow up. Ocular adverse reactions led to permanent discontinuation of ELAHERE in 0.6% of patients.
Premedication and use of lubricating and ophthalmic topical steroid eye drops during treatment with ELAHERE are recommended [see Dosage and Administration (2.3)]. Advise patients to avoid use of contact lenses during treatment with ELAHERE unless directed by a healthcare provider.
Refer patients to an eye care professional for an ophthalmic exam including visual acuity and slit lamp exam prior to treatment initiation, every other cycle for the first 8 cycles, and as clinically indicated. Promptly refer patients to an eye care professional for any new or worsening ocular signs and symptoms.
Monitor for ocular toxicity and withhold, reduce, or permanently discontinue ELAHERE based on severity and persistence of ocular adverse reactions. [see Dosage and Administration (2.4)].
5.2 Pneumonitis
Severe, life-threatening, or fatal interstitial lung disease (ILD), including pneumonitis, can occur in patients treated with ELAHERE.
Pneumonitis occurred in 10% of patients treated with ELAHERE, including 0.8% with Grade 3 events, and 1 patient (0.2%) with a Grade 4 event. One patient (0.2%) died due to respiratory failure in the setting of pneumonitis and lung metastases. Pneumonitis resulted in ELAHERE dose reduction in 1%, dose interruptions in 3%, and permanent discontinuation in 3% of patients.
Monitor patients for pulmonary signs and symptoms of pneumonitis, which may include hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic exams. Infectious, neoplastic, and other causes for such symptoms should be excluded through appropriate investigations. Withhold ELAHERE for patients who develop persistent or recurrent Grade 2 pneumonitis until symptoms resolve to ≤ Grade 1 and consider dose reduction. Permanently discontinue ELAHERE in all patients with Grade 3 or 4 pneumonitis [see Dosage and Administration (2.4)]. Patients who are asymptomatic may continue dosing of ELAHERE with close monitoring.
5.3 Peripheral Neuropathy
Peripheral neuropathy occurred in 36% of patients with ovarian cancer treated with ELAHERE across clinical trials; 2% of patients experienced Grade 3 peripheral neuropathy. Peripheral neuropathy adverse reactions included peripheral neuropathy (19%), peripheral sensory neuropathy (9%), paraesthesia (6%), neurotoxicity (3%), hypoaesthesia (2%), peripheral motor neuropathy (1%), neuralgia (0.4%), polyneuropathy (0.2%) and oral hypoesthesia (0.2%).
The median time to onset of peripheral neuropathy was 1.3 months (range 0.03 to 29.1). Of the patients who experienced peripheral neuropathy, 28% had complete resolution and 13% had partial improvement (defined as a decrease in severity by one or more grades from the worst grade) at last follow up. Peripheral neuropathy led to discontinuation of ELAHERE in 0.4% of patients.
Monitor patients for signs and symptoms of neuropathy, such as paresthesia, tingling or a burning sensation, neuropathic pain, muscle weakness, or dysesthesia. For patients experiencing new or worsening peripheral neuropathy, withhold dosage, dose reduce, or permanently discontinue ELAHERE based on the severity of peripheral neuropathy [see Dosage and Administration (2.4)].
5.4 Embryo-Fetal Toxicity
Based on its mechanism of action, ELAHERE can cause embryo-fetal harm when administered to a pregnant woman because it contains a genotoxic compound (DM4) and affects actively dividing cells.
Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with ELAHERE and for 7 months after the last dose [see Use in Specific Populations (8.1, 8.3)].
6. Adverse Reactions/Side Effects
The following adverse reactions are discussed elsewhere in the labeling:
- Ocular Disorders [see Warnings and Precautions (5.1)].
- Pneumonitis [see Warnings and Precautions (5.2)].
- Peripheral Neuropathy [see Warnings and Precautions (5.3)].
6.1 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 pooled safety population described in WARNINGS AND PRECAUTIONS reflect exposure to ELAHERE in 464 patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer at 6 mg/kg AIBW administered intravenously once every 3 weeks until disease progression or unacceptable toxicity in Study 0417; Study 0403 (NCT02631876), and Study 0401 (NCT01609556). The median duration of treatment was 4.3 months (range: 0.7 to 30.4).
8. Use In Specific Populations
8.3 Females and Males of Reproductive Potential
ELAHERE can cause embryo-fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)].
8.4 Pediatric Use
Safety and effectiveness of ELAHERE have not been established in pediatric patients.
8.5 Geriatric Use
Of the 106 patients who were treated in Study 0417, 44% of patients were ≥65 years old. Grade ≥3 adverse reactions occurred in 49% of patients ≥65 years and in 51% <65 years. No clinically meaningful differences in efficacy or safety were observed between patients ≥65 years of age compared to younger patients.
Population pharmacokinetic analysis indicates that age does not have a clinically meaningful effect on the pharmacokinetics of ELAHERE [see Clinical Pharmacology (12.3)].
8.6 Renal Impairment
No dosage adjustment of ELAHERE is recommended for patients with mild to moderate renal impairment (CLcr 30 to 90 mL/min). The effect of severe renal impairment (CLcr 15 to < 30 mL/min) or end-stage renal disease on ELAHERE is unknown [see Clinical Pharmacology (12.3)].
8.7 Hepatic Impairment
Avoid use of ELAHERE in patients with moderate or severe hepatic impairment (total bilirubin >1.5 ULN).
No dosage adjustment of ELAHERE is recommended for patients with mild hepatic impairment (total bilirubin ≤ULN and AST >ULN or total bilirubin >1 to 1.5 times ULN and any AST) [see Clinical Pharmacology (12.3)].
11. Elahere Injection Description
Mirvetuximab soravtansine-gynx is a folate receptor alpha (FRα)-directed antibody-drug conjugate (ADC) consisting of three components: 1) an anti-FRα monoclonal antibody of IgG1 subtype 2) the small molecule anti-tubulin agent DM4 (a maytansine derivative) and 3) a linker, sulfo-SPDB (1-(2,5-dioxopyrrolidin-1-yl)oxy-1-oxo-4-(pyridin-2-yldisulfanyl)butane-2-sulfonic acid) that covalently attaches DM4 to the mirvetuximab antibody. Mirvetuximab soravtansine-gynx has an approximate molecular weight of 150 kDa. An average of 3.4 molecules of DM4 are attached to each antibody molecule. Mirvetuximab soravtansine-gynx is produced by chemical conjugation of the antibody and small molecule components. The antibody is produced by mammalian (Chinese hamster ovary) cells, and the small molecule components are produced by chemical synthesis.
Mirvetuximab soravtansine-gynx has the following structure:
ELAHERE (mirvetuximab soravtansine-gynx) injection is supplied as a sterile, preservative-free, clear to slightly opalescent, colorless solution containing 100 mg/20 mL of mirvetuximab soravtansine-gynx in single-dose vials. Each mL of solution contains 5 mg of mirvetuximab soravtansine-gynx, and glacial acetic acid (0.22 mg), polysorbate 20 (0.1 mg), sodium acetate (0.53 mg), sucrose (90 mg), and Water for Injection. The pH is approximately 5.0.
The ELAHERE vial stoppers are not made with natural rubber latex.
12. Elahere Injection - Clinical Pharmacology
12.1 Mechanism of Action
Mirvetuximab soravtansine-gynx is an antibody-drug conjugate (ADC). The antibody is a chimeric IgG1 directed against folate receptor alpha (FRα). The small molecule, DM4, is a microtubule inhibitor attached to the antibody via a cleavable linker. Upon binding to FRα, mirvetuximab soravtansine-gynx is internalized followed by intracellular release of DM4 via proteolytic cleavage. DM4 disrupts the microtubule network within the cell, resulting in cell cycle arrest and apoptotic cell death.
12.3 Pharmacokinetics
The pharmacokinetics were characterized after patients were administered mirvetuximab soravtansine-gynx 0.161 mg/kg to 8.71 mg/kg adjusted ideal body weight (AIBW) dosages, (0.0268 times to 1.45 times the approved recommended dosage of 6 mg/kg AIBW), unless otherwise noted.
Table 6 summarizes the exposure parameters of mirvetuximab soravtansine-gynx, unconjugated DM4, and its metabolite S-methyl-DM4 following administration after the first cycle (3-weeks) of mirvetuximab soravtansine-gynx 6 mg/kg to patients. Peak mirvetuximab soravtansine-gynx concentrations were observed near the end of intravenous infusion, while peak unconjugated DM4 concentrations were observed on the second day after administration of mirvetuximab soravtansine-gynx, and the peak S-methyl-DM4 concentrations were observed approximately 3 days after administration of mirvetuximab soravtansine-gynx. Steady state concentrations of mirvetuximab soravtansine-gynx, DM4, and S-methyl-DM4 were reached after 1 treatment cycle. Accumulation of the mirvetuximab soravtansine-gynx, DM4, and S-methyl-DM4 was minimal following repeat administration of mirvetuximab soravtansine-gynx.
| Mirvetuximab Soravtansine-gynx Mean (±SD) | Unconjugated DM4 Mean (±SD) | S-methyl-DM4 Mean (±SD) |
|
|---|---|---|---|
| Cmax = maximum concentration, AUCtau = area under the concentration vs. time curve over the dosing interval (21 days). | |||
| Cmax | 137.3 (±62.3) µg/mL | 4.11 (±2.29) ng/mL | 6.98 (±6.79) ng/mL |
| AUCtau | 20.65 (±6.84) h*mg/mL | 530 (±245) h*ng/mL | 1848 (±1585) h*ng/mL |
12.6 Immunogenicity
As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation against mirvetuximab soravtansine-gynx is highly dependent on the sensitivity and specificity of the assay. The observed incidence of anti-drug antibodies (including neutralizing antibody) is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies to mirvetuximab soravtansine-gynx in other studies.
With a median duration of treatment of 4.3 months in Studies 0417, 0401, and 0403, a total of 55/423 (13%) ovarian cancer patients treated with mirvetuximab soravtansine-gynx at 6 mg/kg AIBW had at least 1 post-baseline positive sample for anti-mirvetuximab soravtansine-gynx antibodies. Of those patients, 28/423 patients (7%) had developed treatment-emergent ADA and 3/423 patients (0.7%) had treatment-enhanced ADA. Neutralizing antibodies were detected in 24/423 (6%) of patients.
Because of the low occurrence of anti-mirvetuximab soravtansine-gynx antibodies, the effect of these antibodies on the pharmacokinetics, efficacy, and/or safety of mirvetuximab soravtansine-gynx is unknown.
13. Nonclinical Toxicology
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity studies have not been conducted with mirvetuximab soravtansine-gynx or DM4.
DM4 and the metabolite, S-methyl DM4, were clastogenic in the in vivo rat bone marrow micronucleus study. DM4 and S-methyl DM4 were not mutagenic in the bacterial reverse mutation (Ames) assay.
Fertility studies have not been conducted with mirvetuximab soravtansine-gynx or DM4.
14. Clinical Studies
The efficacy of ELAHERE was evaluated in Study 0417 (NCT04296890), a single-arm trial of patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer (n=106). Patients were permitted to receive up to three prior lines of systemic therapy. All patients were required to have received prior bevacizumab. The trial enrolled patients whose tumors were positive for FRα expression as determined by the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay. Patients were excluded if they had corneal disorders, ocular conditions requiring ongoing treatment, Grade >1 peripheral neuropathy, or noninfectious interstitial lung disease.
Patients received ELAHERE 6 mg/kg (based on adjusted ideal body weight) as an intravenous infusion every 3 weeks until disease progression or unacceptable toxicity. Tumor response assessments occurred every 6 weeks for the first 36 weeks and every 12 weeks thereafter.
The major efficacy outcome measures were investigator-assessed overall response rate (ORR) and duration of response (DOR) evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
The efficacy evaluable population included 104 patients with platinum-resistant disease, who had measurable disease, and received at least one dose of ELAHERE. In these 104 patients, the median age was 62 years (range: 35 to 85); 96% were White, 2% were Asian, and 2% did not have race reported. Two percent of patients were Hispanic or Latino. All patients had an ECOG PS of 0 (57%) or 1 (43%). Ten percent of patients had received 1 prior line of systemic therapy, 39% of patients had received 2 prior lines of systemic therapy, and 50% of patients had received 3 prior lines of systemic therapy. All patients had received prior bevacizumab and 47% had received a prior PARP inhibitor.
Efficacy results for Study 0417 are summarized in Table 7.
| ELAHERE (N=104) |
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|---|---|
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| Confirmed Overall Response Rate*
(95% CI) | 31.7% (22.9, 41.6) |
| Complete response rate | 4.8% |
| Partial response rate | 26.9% |
| Duration of Response | N=33 |
| Median duration of response, months (95% CI) | 6.9 (5.6, 9.7) |
Response assessment results using independent radiology review were consistent with investigator assessment.
17. Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
| MEDICATION GUIDE ELAHERE (el-ah-HERE) (mirvetuximab soravtansine-gynx) injection, for intravenous use |
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| This Medication Guide has been approved by the U.S. Food and Drug Administration. | Issued 11 2022 | ||
| What is the most important information I should know about ELAHERE? ELAHERE can cause serious side effects, including:
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| What is ELAHERE?
ELAHERE is a prescription medicine used to treat adults with folate receptor-alpha positive ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who:
It is not known if ELAHERE is safe and effective in children. |
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Before receiving ELAHERE, tell your healthcare provider about all of your medical conditions, including if you:
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How will I receive ELAHERE?
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| What are the possible side effects of ELAHERE? ELAHERE can cause serious side effects, including:
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| Your healthcare provider may change your dose of ELAHERE, delay treatment, or completely stop treatment if you have certain side effects. These are not all of the possible side effects of ELAHERE. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
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| General information about the safe and effective use of ELAHERE.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. If you would like more information about ELAHERE, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about ELAHERE that is written for healthcare professionals. |
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| What are the ingredients in ELAHERE?
Active ingredient: mirvetuximab soravtansine-gynx Inactive ingredients: glacial acetic acid, polysorbate 20, sodium acetate, sucrose, Water for Injection. Manufactured by: ImmunoGen, Inc., Waltham, MA 02451 U.S. License 2288 ELAHERE™ is a trademark owned by ImmunoGen, Inc. ©2022 ImmunoGen, Inc. For more information, go to www.immunogen.com or call 1-833-486-4646. |
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| ELAHERE
mirvetuximab soravtansine injection, solution |
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| Labeler - ImmunoGen, Inc. (011991874) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| BSP Pharmaceuticals S.p.A. | 857007830 | MANUFACTURE(72903-853) , ANALYSIS(72903-853) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| AndersonBrecon, Inc. (doing business as PCI Pharma Services) | 098908572 | LABEL(72903-853) , PACK(72903-853) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Boehringer Ingelheim Pharma GmbH & Co. KG | 340700520 | API MANUFACTURE(72903-853) , ANALYSIS(72903-853) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Element Materials Technology Pharma US, LLC | 081315325 | ANALYSIS(72903-853) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Millipore Sigma | 605899769 | API MANUFACTURE(72903-853) , ANALYSIS(72903-853) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Sicor S.r.l | 338950678 | API MANUFACTURE(72903-853) , ANALYSIS(72903-853) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Millipore Sigma | 833146777 | ANALYSIS(72903-853) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
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| BioReliance Corporation | 147227730 | ANALYSIS(72903-853) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
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| BioReliance Ltd. | 505004556 | ANALYSIS(72903-853) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Eurofins Biolab S.r.l | 429117112 | ANALYSIS(72903-853) | |
