Use in Adults
CGRP Monoclonal Antibodies
THIS GUIDE PROVIDES A PARTIAL LISTING OF PRESCRIBING INFORMATION FOR THIS MEDICATION. FOR A FULL LISTING OF PRESCRIBING INFORMATION PLEASE REFER TO THE PACKAGE INSERT. CLICK ON THE BRAND NAME® TO VIEW THE LINK TO THE PACKAGE INSERT.
EPTINEZUMAB (VYEPTI®) FDA APPROVED FOR MIGRAINE PREVENTION CLICK HERE TO EXPAND
Brands: Available Dosages:
Suggested Titration Schedule:
Precautions and Risk:
Contraindications:
Pregnancy & Breast Feeding:
- 100 and 300 mg dosage by intravenous infusion
- 100 mg intravenously is the most common initial dosage
- 300 mg might be given in those with a BMI ≥ 30 as some studies suggest that this dosage might be more effective in this population
- 100 mg or 300 mg intravenously every 3 months
- Might consider 300 mg intravenously every 3 months in those with BMI ≥ 30
Suggested Titration Schedule:
- 100 mg Dosage
- Office visit #1: Start with 100 mg intravenous dosage every 3 months
- Office visit #2 (3 months later): Assess efficacy
- If improved would continue the medications at its current dosage
- Remember that a good response to a preventive medication would be a 50% or greater reduction in the frequency of migraine days per month compared to the time period prior to start of the medication
- If unchanged would consider increasing the dosage to 300 mg intravenously every 3 months
- If the frequency of migraines has worsened, then would stop the medication
- Nasopharyngitis
- Hypersensitivity reactions
- Rash, facial flushing and hivers
- Might consider its use in:
- Those with episodic or chronic migraine who have not responded to 1-2 medication classes of migraine preventives
- Those medication overuse headache and migraine disease
- Those who are risk for job loss or social disruption because of disabling migraine and who could benefit from an early response to a migraine preventive, since eptinezumab has clinical trial data showing benefit within 24 hours for some patients
- Those with migraine who experienced multiple medication intolerances or had contraindications to oral migraine preventives.
- Those who struggle to remember daily oral migraine preventives; a quarterly injection might improve compliance.
- Might avoid its use in:
- Those with significant cardiovascular disease as safety in this population has not been well established
- Those who are “needle phobic”
- Main advantages are:
- Good efficacy, low side effect profile and rapid onset of action.
- Main disadvantages are:
- Need for equipment and nursing staff to administer eptinezumab intravenously
- Cost and need for a prior authorization.
- Often insurers will require that a patient has not responded to 1-2 past preventive medication classes before approval of a CGRP monoclonal antibody.
- Some insurers may also require failure of 1-2 subcutaneous MABs prior to approval of the iv eptinezumab.
- Most headache specialists would recommend a 6 month trial of eptinezumab to access its efficacy.
Precautions and Risk:
- Hypersensitivity Reactions: Reactions have included angioedema, urticaria, facial flushing, and rash
- Pregnancy & lactation: unknown; consider discontinuing for 3 to 5 half-lives before conceiving.
Contraindications:
- Would avoid in those with recent cardiovascular events in the prior 6 months as these participants were excluded from the clinical trials
Pregnancy & Breast Feeding:
- Click Vyepti® and navigate to #8 Use in Specific Populations (8.1 & 8.2)
- There are no known significant interactions.
- Consider starting a preventive therapy in those with 4 or more migraine days per month.
- Have the patients keep a headache diary to assess the frequency of migraine days per month. This will also help in assessing the response of the preventive medication.
- Set realistic goals with your patients. Explain that a preventive medication is not a cure for migraines. A good response would be a 50% or more reduction in the frequency of migraine days per month or for some, a significant reduction in severity of migraine attacks.
- Offer a 6 month trial of this medication to access efficacy.
- Counsel patients on side effects or they may discontinue the medication.
- Requires IV infusion; patients may receive their infusion at an infusion center or in-office if appropriate staff and equipment are available.
- Infused eptinezumab over 30 minutes
ERENUMAB (AIMOVIG®) FDA APPROVED FOR MIGRAINE PREVENTION CLICK HERE TO EXPAND
Brands: Available Dosages:
Common and Rarer Side Effects:
Precautions and Risk:
- 70 and 140 mg autoinjectors
- 70 mg or 140 mg subcutaneously monthly
- 70 mg or 140 mg subcutaneously monthly
- Office visit #1:
- Start with the 70 mg dosage subcutaneously monthly for most patients
- Office visit #2 (2 months later):
- If satisfactory response (e.g., defined as a 50% decrease in the frequency of migraine days per month) or marked reduction in severity of attacks
- Continue current dosage if no unacceptable side effects
- If unsatisfactory response and no intolerable side effects
- If started with 70 mg dosage, then might consider increasing dosage to 140 mg
- If started with the 140 mg dosage, then continue this dosage
- Continue this medication for another 2-3 months to assess its efficacy as it may take 4-5 months of use to see an effect
Common and Rarer Side Effects:
- Injection site pain (most common)
- Constipation
- Hypertension (rare)
- Erenumab was the first of the CGRP monoclonal antibodies.
- Might consider erenumab in the following patients:
- Those with episodic or chronic migraine that have found 1-2 preventative medication classes either ineffective, intolerable, or contraindicated.
- Patients with medication overuse headache in addition to migraine disease
- Those with migraine that experience multiple medication intolerances
- Those patients who struggle with taking daily preventive meds; a once monthly injection may enhance compliance.
- Those who prefer not to take a daily administered preventive medication.
- Those who need migraine preventive help more quickly, either because of severity, frequency, or to avoid further disruption in work and activities of daily life (as the drug has shown early efficacy; it may begin to work in 1-2 weeks)
- Might avoid its use in:
- Those with significant cardiovascular disease as safety in this population has not been well established
- Moderate to severe constipation
- Those that have a fear of needles or have difficulty administering an injection to themselves
- Main advantages are:
- Good efficacy, low side effect profile and rapid onset of action.
- Main disadvantages are: Cost and need for a prior authorization.
- Often insurers will require that a patient has not responded to 1-2 migraine preventive medication classes before approval of CGRP monoclonal antibodies.
- Most headache specialists would recommend a 4-5 month trial of a CGRP monoclonal to assess efficacy.
Precautions and Risk:
- Cardiovascular: Development or worsening of hypertension have been reported, including cases requiring treatment and hospitalization, and may occur at any time during treatment. Risk is increased in patients with preexisting hypertension which is uncontrolled or with unaddressed risk factors for hypertension. Monitoring is recommended, and treatment and discontinuation may be necessary.
- Gastrointestinal: Constipation with serious complications, including hospitalization and surgery, has been reported in post-marketing experience; onset was after the first dose in most cases but may also occur later in treatment; concomitant use of medications that decrease gastrointestinal motility may increase severity and complications; monitor and manage medically.
- Immunologic: Hypersensitivity reactions, including rash, angioedema, and anaphylaxis, have been reported; usually occurring within hours of administration but some occurred more than 1 week after administration. Discontinue if a serious or severe hypersensitivity reaction occurs and manage medically
- Would avoid in those with hypersensitivity reactions to erenumab
- Would avoid in those with recent cardiovascular events in the prior 6 months as these participants were excluded from the clinical trials.
- Click Aimovig® and navigate to #8 Use in Specific Populations (8.1 & 8.2)
- There are no known significant interactions.
- Consider starting a preventive therapy in those with 4 or more migraine days per month.
- Have the patients keep a headache diary to assess the frequency of migraine days per month. This will also help in assessing the response of the preventive medication.
- The monoclonal antibiotics have shown benefit in reduction of migraine attacks (in clinical trials as early as 1-4 weeks after their initiation. This is markedly different from most of the oral preventives, which typically begin to prevent migraine attacks 1-2 months after initiation. Exceptions may include topiramate and some gepants.
- Set realistic goals with your patients. Explain that a preventive medication is not a cure for migraines. A good response would be a 50% or more reduction in the frequency of migraine days per month or a marked reduction in migraine severity.
- Allow a 4-5 month trial of this medication to access efficacy.
- Counsel patients on side effects.
- Include careful instructions of use of autoinjector. May want to demonstrate in office.
- Greater efficacy with the 140 mg dosage was reported in the clinical trials. If an optimal dosage is not observed with the 70mg dosage, increase to 140mg monthly.
Fremanezumab (Ajovy®) FDA APPROVED FOR MIGRAINE PREVENTION CLICK HERE TO EXPAND
Ajovy® (fremanezumab) For Complete Prescribing Information Click Here for the Package Insert
Available Dosages:
Common and Rarer Side Effects:
Precautions and Risks:
Available Dosages:
- 225 mg autoinjector or prefilled syringes
- 225 mg subcutaneously monthly or
- 675 mgs subcutaneously every 3 months
- Quarterly dosing might be preferred by some patients.
- Might also be preferred if injections need to be administered in the office because patients cannot administer them.
- 225 mg subcutaneously monthly or 675 mg subcutaneously every 3 months
- Monthly dosing schedule
- Office visit #1:
- Start with 225 mg dosage subcutaneously monthly
- Office visit #2 (2 months later):
- Assess response to therapy
- If the frequency of migraines has worsened, then would stop the medication
- If unchanged or improved would continue the medications for 4-5 months to assess its efficacy
- A good response to a preventive medication would be a 50% or greater reduction in the frequency of migraine days per month compared to the time period prior to start of the medication
- Quarterly dosing schedule
- Office visit #1:
- Start with 675 mg dosage subcutaneously every 3 months
- Office visit #2 (2 months later):
- Assess response to therapy
- If the frequency of migraines has worsened, then would stop the medication
- If unchanged or improved would continue the medications for 4-5 months to assess its efficacy
- A good response to a preventive medication would be a 50% or greater reduction in the frequency of migraine days per month compared to the time period prior to start of the medication
- Office visit #1:
Common and Rarer Side Effects:
- Injection site reactions
- Rarer: anaphylaxis, hypersensitivity reactions
- Might consider its use in:
- Those with episodic or chronic migraine who have not responded to 1-2 medication classes of migraine preventives
- Those with medication overuse headache and co-existing migraine
- Those with migraine who experienced multiple medication intolerances with previously tried migraine preventives
- Those having poor compliance with daily administration of preventive meds; a monthly or quarterly dosing schedule might improve compliance.
- Those that need to improve as soon as possible since they have a rapid onset of action.
- Might avoid its use in:
- Those with significant cardiovascular disease as safety in this population has not been well established
- Those that have a fear of needles or have difficulty administering an injection to themselves
- Main advantages are:
- Good efficacy, low side effect profile and rapid onset of action.
- Some patients may prefer quarterly dosing receiving three injections every 3 months as opposed to one injection per month.
- Quarterly dosing might be a better option for the patient that is needle phobic and cannot self-administer injections.
- In that situation the injections might be administered in the office or by a trained individual at home. Also, may be beneficial to patients who travel frequently, or have erratic schedules
- Main disadvantages are:
- Cost and need for a prior authorization.
- Often insurers will require that a patient not respond to 1-2 past preventive migraine medication classes before approval of a CGRP monoclonal antibody.
- Most headache specialists would recommend a 4-5 month trial of CGRP monoclonal to assess efficacy.
Precautions and Risks:
- Hypersensitivity: Hypersensitivity reactions, including anaphylaxis, angioedema, rash, pruritus, drug hypersensitivity, and urticaria, have been reported. Most reactions were mild to moderate and were reported from within hours to 1 month after administration. If a hypersensitivity reaction occurs, consider discontinuing treatment and institute appropriate therapy.
- Cardiovascular disease: Patients with a history of significant cardiovascular disease, vascular ischemia, or thrombotic events, such as cerebrovascular accident, transient ischemic attacks, deep vein thrombosis, or pulmonary embolism were excluded from clinical trials; use with caution in these patients.
- Click Ajovy® and navigate to #8 Use in Specific Populations (8.1 & 8.2)
- Would avoid in those with hypersensitivity reactions to fremanezumab
- Would avoid in those with recent cardiovascular events in the prior 6 months as these participants were excluded from the clinical trials.
- There are no known significant interactions.
- Consider starting a preventive therapy in those with 4 or more migraine days per month.
- Have the patients keep a headache diary to assess the frequency of migraine days per month. This will also help in assessing the response of the preventive medication.
- The monoclonal antibiotics may begin to prevent headaches as early as 1-4 weeks after their initiation. This is different from many of the oral preventives, which typically begin to prevent migraine attacks 1-2 months after initiation. One exception to this rule is the gepants that might also begin to work as early as 1 week.
- Set realistic goals with your patients. Tell them that a preventive medication is not a cure for migraines. A good response would be a 50% or more reduction in the frequency of migraine days per month.
- Offer a 4-5 month trial of this medication to assess efficacy.
- Counsel patients on side effects or they may discontinue the medication.
- Can offer the option of monthly or quarterly dosing.
- Available as an auto-injector and a pre-filled syringe, both containing 225 mg. Must be instructed on use of autoinjector or pre-filled syringe. Most patients prefer the autoinjector. However, pre-filled syringes may be useful for patients that find the autoinjector painful.
Galcanezumab (AIMOVIG®) FDA APPROVED FOR MIGRAINE PREVENTION CLICK HERE TO EXPAND
Emgality® (galcanezumab) For Complete Prescribing Information Click Here for the Package Insert
Available Dosages:
Would avoid in those with recent cardiovascular events in the prior 6 months as these participants were excluded from the clinical trials.
Counseling Tips:
Available Dosages:
- 120 mg subcutaneous pen injectors
- 240 mg subcutaneously one time as a loading dose
- 120 mg subcutaneously monthly
- Office visit #1:
- Start with a loading dosage of 240 mg dosage subcutaneously monthly (two 120 mg injectables)
- Then take a maintenance dosage of 120 mg dosage subcutaneously monthly thereafter
- Office visit #2 (2 months later):
- Assess efficacy
- If the frequency of migraines has worsened, then would stop the medication
- If unchanged or improved would continue the medications for 4-5 months to assess its efficacy
- Remember that a good response to a preventive medication would be a 50% or greater reduction in the frequency of migraine days per month compared to the time period prior to start of the medication
- Injection site reactions (most common)
- Rare: anaphylaxis, hypersensitivity reactions
- Might consider in the following patients:
- Those with episodic or chronic migraine that have found 1-2 preventative medication classes either ineffective, intolerable, or contraindicated.
- Patients with medication overuse headache in addition to migraine disease
- Those with migraine that experience multiple medication intolerances
- Those patients who struggle with taking daily preventive meds; a once monthly injection may enhance compliance.
- Those who prefer not to take a daily administered preventive medication.
- Those who need migraine preventive help more quickly, either because of severity, frequency, or to avoid further disruption in work and activities of daily life (as the drug has shown early efficacy; it may begin to work in 1-2 weeks)
- Might avoid its use in:
- Those with significant cardiovascular disease as safety in this population has not been well established
- Those that have a fear of needles or have difficulty administering an injection to themselves
- Main advantages are:
- Good efficacy, low side effect profile and rapid onset of action.
- Main disadvantages are:
- Cost and need for a prior authorization.
- Often insurers will require that a patient has not responded to 1-2 migraine preventive medication classes before approval of CGRP monoclonal antibodies.
- Most headache specialists would recommend a 4-5 month trial of a CGRP monoclonal to assess efficacy.
- Hypersensitivity: hypersensitivity reactions, including anaphylaxis, angioedema, dyspnea, rash, and urticaria have been reported; reactions may occur days after administration and may be prolonged. Discontinue use and initiate appropriate therapy if hypersensitivity reactions occur.
- Cardiovascular disease: Patients with ECG abnormalities compatible with an acute cardiovascular event and patients with a recent history (within 6 months) of stroke, myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass grafting, deep vein thrombosis, or pulmonary embolism were excluded from clinical trials; use with caution in these patients.
- Peripheral vascular disease: Patients with history of stroke, intracranial or carotid aneurysm, intracranial hemorrhage, vasospastic angina or Raynaud disease, or clinical evidence of peripheral vascular disease were excluded from cluster headache clinical trials; use with caution in these patients.
- There are no known significant interactions.
- Click Emgality® and navigate to #8 Use in Specific Populations (8.1 & 8.2)
Would avoid in those with recent cardiovascular events in the prior 6 months as these participants were excluded from the clinical trials.
Counseling Tips:
- Consider starting a preventive therapy in those with 4 or more migraine days per month.
- Have the patients keep a headache diary to assess the frequency of migraine days per month. This will also help in assessing the response of the preventive medication.
- The monoclonal antibiotics may begin to prevent headaches as early as 1-4 weeks after their initiation. This is different from many of the oral preventives, which typically begin to prevent migraine attacks 1-2 months after initiation. One exception to this rule is the gepants that might also begin to work as early as 1 week.
- Set realistic goals with your patients. Tell them that a preventive medication is not a cure for migraines. A good response would be a 50% or more reduction in the frequency of migraine days per month.
- Give them a 4-5 month trial of this medication to access efficacy.
- Counsel patients on side effects or they may discontinue the medication.