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Drug overview for AJOVY SYRINGE (fremanezumab-vfrm):
Generic name: fremanezumab-vfrm (FREE-ma-NEZ-ue-mab)
Drug class: Migraine Prevention Medications
Therapeutic class: Central Nervous System Agents
Fremanezumab, a recombinant fully humanized immunoglobulin G2a (IgG2a) monoclonal antibody specific for calcitonin gene-related peptide (CGRP) ligand, is an antimigraine agent.
No enhanced Uses information available for this drug.
Generic name: fremanezumab-vfrm (FREE-ma-NEZ-ue-mab)
Drug class: Migraine Prevention Medications
Therapeutic class: Central Nervous System Agents
Fremanezumab, a recombinant fully humanized immunoglobulin G2a (IgG2a) monoclonal antibody specific for calcitonin gene-related peptide (CGRP) ligand, is an antimigraine agent.
No enhanced Uses information available for this drug.
DRUG IMAGES
AJOVY 225 MG/1.5 ML SYRINGE
The following indications for AJOVY SYRINGE (fremanezumab-vfrm) have been approved by the FDA:
Indications:
Migraine prevention
Professional Synonyms:
Migraine prophylaxis
Indications:
Migraine prevention
Professional Synonyms:
Migraine prophylaxis
The following dosing information is available for AJOVY SYRINGE (fremanezumab-vfrm):
For the preventive treatment of migraine in adults, the recommended dosage of fremanezumab-vfrm is 225 mg once monthly or 675 mg every 3 months (quarterly) by subcutaneous injection. The 675-mg dose should be administered as 3 consecutive subcutaneous injections of 225 mg each. There does not appear to be a need for dosage titration with fremanezumab-vfrm; therapy may be initiated with either the 225-mg monthly dose or the 675-mg quarterly dose.
When switching dosage regimens, the first dose of the new dosage regimen should be administered on the next scheduled date of administration.
If a dose of fremanezumab-vfrm is missed, the missed dose should be administered as soon as possible. Subsequent doses may then be scheduled monthly (225-mg doses) or every 3 months (675-mg doses) from the date of the last administered dose.
The risk of adverse drug interactions with fremanezumab appears to be minimal. When initiating therapy with fremanezumab or another calcitonin gene-related peptide (CGRP) antagonist in a patient who is already receiving a preventive treatment for migraine, the American Headache Society (AHS) recommends adding the CGRP antagonist to the existing antimigraine regimen and not making other changes until the clinical efficacy of the CGRP antagonist is determined.
Patients who respond to CGRP antagonist therapy usually respond following the first 3 subcutaneous injections. Therefore, the AHS recommends assessing the clinical efficacy of fremanezumab after 3 months (if using the monthly dosage regimen) or 6 months (if using the quarterly dosage regimen) of treatment and continuing therapy only if treatment benefits have been observed with the drug by that time.
When switching dosage regimens, the first dose of the new dosage regimen should be administered on the next scheduled date of administration.
If a dose of fremanezumab-vfrm is missed, the missed dose should be administered as soon as possible. Subsequent doses may then be scheduled monthly (225-mg doses) or every 3 months (675-mg doses) from the date of the last administered dose.
The risk of adverse drug interactions with fremanezumab appears to be minimal. When initiating therapy with fremanezumab or another calcitonin gene-related peptide (CGRP) antagonist in a patient who is already receiving a preventive treatment for migraine, the American Headache Society (AHS) recommends adding the CGRP antagonist to the existing antimigraine regimen and not making other changes until the clinical efficacy of the CGRP antagonist is determined.
Patients who respond to CGRP antagonist therapy usually respond following the first 3 subcutaneous injections. Therefore, the AHS recommends assessing the clinical efficacy of fremanezumab after 3 months (if using the monthly dosage regimen) or 6 months (if using the quarterly dosage regimen) of treatment and continuing therapy only if treatment benefits have been observed with the drug by that time.
Fremanezumab-vfrm is administered by subcutaneous injection only. Fremanezumab-vfrm injection is commercially available in single-use prefilled syringes and auto-injectors containing 225 mg of the drug in 1.5 mL of solution.
The drug may be administered by healthcare professionals or caregivers and/or self-administered. Prior to use, patients and/or caregivers should receive proper training on how to prepare and administer fremanezumab-vfrm using the single-use prefilled syringes, including aseptic technique. The manufacturer's labeling should be consulted for detailed instructions regarding subcutaneous administration of the drug using the prefilled syringes or auto-injectors.
Fremanezumab-vfrm should be administered subcutaneously into the abdomen, anterior thigh, or back of the upper arm; injections within 2 inches of the navel, knee, or groin should be avoided. Multiple injections of the drug (i.e., to administer a 675-mg dose) may be administered at the same body site, but not at the exact location of the previous injection. Fremanezumab-vfrm should not be administered concomitantly with other parenteral drugs at the same injection site.
Injection into areas where the skin is tender, bruised, erythematous, or indurated should be avoided. Prefilled syringes and auto-injectors of fremanezumab-vfrm should be stored at 2-8degreesC in the original outer carton to protect from light. The syringes and auto-injectors may be stored at room temperature up to 30degreesC in the original carton for up to 7 days; the syringes and auto-injectors should not be returned to the refrigerator after storage at room temperature.
If the syringes or auto-injectors are stored at room temperature for 7 days or more, they should be discarded. The prefilled syringes and auto-injectors should not be frozen, shaken, or exposed to extreme heat or direct sunlight. Prior to subcutaneous administration, prefilled syringes and auto-injectors of fremanezumab-vfrm should be removed from the refrigerator and allowed to sit at room temperature for 30 minutes protected from direct sunlight.
Do not warm the syringes or auto-injectors by using a heat source (e.g., microwave, hot water). Prior to administration, the solution should be inspected visually for particulate matter and discoloration; the syringe or auto-injector should not be used if the solution is cloudy or discolored or contains particles. The prefilled syringes and auto-injectors are intended for single use only and should be discarded after use.
The drug may be administered by healthcare professionals or caregivers and/or self-administered. Prior to use, patients and/or caregivers should receive proper training on how to prepare and administer fremanezumab-vfrm using the single-use prefilled syringes, including aseptic technique. The manufacturer's labeling should be consulted for detailed instructions regarding subcutaneous administration of the drug using the prefilled syringes or auto-injectors.
Fremanezumab-vfrm should be administered subcutaneously into the abdomen, anterior thigh, or back of the upper arm; injections within 2 inches of the navel, knee, or groin should be avoided. Multiple injections of the drug (i.e., to administer a 675-mg dose) may be administered at the same body site, but not at the exact location of the previous injection. Fremanezumab-vfrm should not be administered concomitantly with other parenteral drugs at the same injection site.
Injection into areas where the skin is tender, bruised, erythematous, or indurated should be avoided. Prefilled syringes and auto-injectors of fremanezumab-vfrm should be stored at 2-8degreesC in the original outer carton to protect from light. The syringes and auto-injectors may be stored at room temperature up to 30degreesC in the original carton for up to 7 days; the syringes and auto-injectors should not be returned to the refrigerator after storage at room temperature.
If the syringes or auto-injectors are stored at room temperature for 7 days or more, they should be discarded. The prefilled syringes and auto-injectors should not be frozen, shaken, or exposed to extreme heat or direct sunlight. Prior to subcutaneous administration, prefilled syringes and auto-injectors of fremanezumab-vfrm should be removed from the refrigerator and allowed to sit at room temperature for 30 minutes protected from direct sunlight.
Do not warm the syringes or auto-injectors by using a heat source (e.g., microwave, hot water). Prior to administration, the solution should be inspected visually for particulate matter and discoloration; the syringe or auto-injector should not be used if the solution is cloudy or discolored or contains particles. The prefilled syringes and auto-injectors are intended for single use only and should be discarded after use.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| AJOVY 225 MG/1.5 ML SYRINGE | Maintenance | Adults inject 225 mg by subcutaneous route once a month in the abdomen, thigh, or upper arm |
No generic dosing information available.
The following drug interaction information is available for AJOVY SYRINGE (fremanezumab-vfrm):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for AJOVY SYRINGE (fremanezumab-vfrm):
Drug contraindication overview.
*Serious hypersensitivity to fremanezumab or to any excipients in the formulation.
*Serious hypersensitivity to fremanezumab or to any excipients in the formulation.
There are 0 contraindications.
There are 0 severe contraindications.
There are 2 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Hypertension |
| Raynaud's phenomenon |
The following adverse reaction information is available for AJOVY SYRINGE (fremanezumab-vfrm):
Adverse reaction overview.
Adverse effects reported in >=5% of patients receiving fremanezumab-vfrm for preventive treatment of migraine in clinical studies and more frequently than with placebo include injection site reactions (e.g., pain, induration, erythema), most of which were mild to moderate in severity and self-limited.
Adverse effects reported in >=5% of patients receiving fremanezumab-vfrm for preventive treatment of migraine in clinical studies and more frequently than with placebo include injection site reactions (e.g., pain, induration, erythema), most of which were mild to moderate in severity and self-limited.
There are 3 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Anaphylaxis Angioedema Hypersensitivity drug reaction |
There are 6 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Injection site sequelae |
None. |
| Rare/Very Rare |
|---|
|
Hypertension Pruritus of skin Raynaud's phenomenon Skin rash Urticaria |
The following precautions are available for AJOVY SYRINGE (fremanezumab-vfrm):
The manufacturer states that the safety and efficacy of fremanezumab have not been established in pediatric patients. Pending further clinical experience with the use of calcitonin gene-related peptide (CGRP) antagonists in pediatric patients, the Pediatric and Adolescent Headache special interest group of the American Headache Society (AHS) recommends that CGRP antagonists (e.g., erenumab, fremanezumab, galcanezumab) should be considered mainly for use in postpubertal adolescents+ with relatively frequent migraines (i.e., 8 or more headache days per month) who have moderate to severe disability associated with migraine (e.g., PedMIDAS score of 30 or more) and in whom at least 2 preventive therapies (including pharmacologic and nonpharmacologic therapies and dietary supplements) have failed. For younger pediatric patients+ with severe chronic migraine that is refractory to multiple preventive therapies, these experts recommend that CGRP antagonists be considered only in carefully selected patients with close monitoring (e.g., pubertal status, bone health, linear growth, weight, body mass index (BMI), infectious complications).
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
There are no adequate data to date on the developmental risk associated with the use of fremanezumab in pregnant women. The manufacturer states that the long elimination half-life of fremanezumab should be considered if the drug is used in women who are pregnant or plan to become pregnant during therapy. Animal studies in pregnant rats and rabbits administered fremanezumab subcutaneously at dosages resulting in systemic exposures up to approximately 2-3 times the exposure from the maximum recommended human dosage (675 mg) did not adversely affect the development of the offspring.
The estimated rates of major birth defects and miscarriage among deliveries to women with migraine (2.2-2.9 and 17%, respectively) are similar to rates reported in women without migraine. Clinicians should be aware that published data suggest that women with migraine may be at increased risk of preeclampsia during pregnancy. A registry that monitors outcomes in women exposed to fremanezumab during pregnancy exists; enrollment in the registry can occur by calling 833-927-2605 or visiting https://www.tevamigrainepregnancyregistry.com.
The estimated rates of major birth defects and miscarriage among deliveries to women with migraine (2.2-2.9 and 17%, respectively) are similar to rates reported in women without migraine. Clinicians should be aware that published data suggest that women with migraine may be at increased risk of preeclampsia during pregnancy. A registry that monitors outcomes in women exposed to fremanezumab during pregnancy exists; enrollment in the registry can occur by calling 833-927-2605 or visiting https://www.tevamigrainepregnancyregistry.com.
It is not known whether fremanezumab is distributed into human milk. The effects of the drug on breast-fed infants and on milk production also are unknown. The manufacturer states that the developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for fremanezumab and any potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition.
Clinical trials of fremanezumab did not include sufficient numbers of patients 65 years of age or older to determine whether they respond differently than younger adults.
The following prioritized warning is available for AJOVY SYRINGE (fremanezumab-vfrm):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for AJOVY SYRINGE (fremanezumab-vfrm)'s list of indications:
| Migraine prevention | |
| G43 | Migraine |
| G43.0 | Migraine without aura |
| G43.00 | Migraine without aura, not intractable |
| G43.001 | Migraine without aura, not intractable, with status migrainosus |
| G43.009 | Migraine without aura, not intractable, without status migrainosus |
| G43.01 | Migraine without aura, intractable |
| G43.011 | Migraine without aura, intractable, with status migrainosus |
| G43.019 | Migraine without aura, intractable, without status migrainosus |
| G43.1 | Migraine with aura |
| G43.10 | Migraine with aura, not intractable |
| G43.101 | Migraine with aura, not intractable, with status migrainosus |
| G43.109 | Migraine with aura, not intractable, without status migrainosus |
| G43.11 | Migraine with aura, intractable |
| G43.111 | Migraine with aura, intractable, with status migrainosus |
| G43.119 | Migraine with aura, intractable, without status migrainosus |
| G43.4 | Hemiplegic migraine |
| G43.40 | Hemiplegic migraine, not intractable |
| G43.401 | Hemiplegic migraine, not intractable, with status migrainosus |
| G43.409 | Hemiplegic migraine, not intractable, without status migrainosus |
| G43.41 | Hemiplegic migraine, intractable |
| G43.411 | Hemiplegic migraine, intractable, with status migrainosus |
| G43.419 | Hemiplegic migraine, intractable, without status migrainosus |
| G43.5 | Persistent migraine aura without cerebral infarction |
| G43.50 | Persistent migraine aura without cerebral infarction, not intractable |
| G43.501 | Persistent migraine aura without cerebral infarction, not intractable, with status migrainosus |
| G43.509 | Persistent migraine aura without cerebral infarction, not intractable, without status migrainosus |
| G43.51 | Persistent migraine aura without cerebral infarction, intractable |
| G43.511 | Persistent migraine aura without cerebral infarction, intractable, with status migrainosus |
| G43.519 | Persistent migraine aura without cerebral infarction, intractable, without status migrainosus |
| G43.6 | Persistent migraine aura with cerebral infarction |
| G43.60 | Persistent migraine aura with cerebral infarction, not intractable |
| G43.601 | Persistent migraine aura with cerebral infarction, not intractable, with status migrainosus |
| G43.609 | Persistent migraine aura with cerebral infarction, not intractable, without status migrainosus |
| G43.61 | Persistent migraine aura with cerebral infarction, intractable |
| G43.611 | Persistent migraine aura with cerebral infarction, intractable, with status migrainosus |
| G43.619 | Persistent migraine aura with cerebral infarction, intractable, without status migrainosus |
| G43.7 | Chronic migraine without aura |
| G43.70 | Chronic migraine without aura, not intractable |
| G43.701 | Chronic migraine without aura, not intractable, with status migrainosus |
| G43.709 | Chronic migraine without aura, not intractable, without status migrainosus |
| G43.71 | Chronic migraine without aura, intractable |
| G43.711 | Chronic migraine without aura, intractable, with status migrainosus |
| G43.719 | Chronic migraine without aura, intractable, without status migrainosus |
| G43.8 | Other migraine |
| G43.80 | Other migraine, not intractable |
| G43.801 | Other migraine, not intractable, with status migrainosus |
| G43.809 | Other migraine, not intractable, without status migrainosus |
| G43.81 | Other migraine, intractable |
| G43.811 | Other migraine, intractable, with status migrainosus |
| G43.819 | Other migraine, intractable, without status migrainosus |
| G43.82 | Menstrual migraine, not intractable |
| G43.821 | Menstrual migraine, not intractable, with status migrainosus |
| G43.829 | Menstrual migraine, not intractable, without status migrainosus |
| G43.83 | Menstrual migraine, intractable |
| G43.831 | Menstrual migraine, intractable, with status migrainosus |
| G43.839 | Menstrual migraine, intractable, without status migrainosus |
| G43.9 | Migraine, unspecified |
| G43.90 | Migraine, unspecified, not intractable |
| G43.901 | Migraine, unspecified, not intractable, with status migrainosus |
| G43.909 | Migraine, unspecified, not intractable, without status migrainosus |
| G43.91 | Migraine, unspecified, intractable |
| G43.911 | Migraine, unspecified, intractable, with status migrainosus |
| G43.919 | Migraine, unspecified, intractable, without status migrainosus |
| G43.B | Ophthalmoplegic migraine |
| G43.B0 | Ophthalmoplegic migraine, not intractable |
| G43.B1 | Ophthalmoplegic migraine, intractable |
| G43.C | Periodic headache syndromes in child or adult |
| G43.C0 | Periodic headache syndromes in child or adult, not intractable |
| G43.C1 | Periodic headache syndromes in child or adult, intractable |
| G43.D | Abdominal migraine |
| G43.D0 | Abdominal migraine, not intractable |
| G43.D1 | Abdominal migraine, intractable |
| G43.E | Chronic migraine with aura |
| G43.E0 | Chronic migraine with aura, not intractable |
| G43.E01 | Chronic migraine with aura, not intractable, with status migrainosus |
| G43.E09 | Chronic migraine with aura, not intractable, without status migrainosus |
| G43.E1 | Chronic migraine with aura, intractable |
| G43.E11 | Chronic migraine with aura, intractable, with status migrainosus |
| G43.E19 | Chronic migraine with aura, intractable, without status migrainosus |
Formulary Reference Tool