What is Nurtec ODT?

Nurtec ODT (rimegepant) is used to treat acute migraine attacks (with or without aura) and is also used to prevent episodic migraines.

Nurtec ODT is a calcitonin gene-related peptide (CGRP) receptor blocker, so it works by blocking CGRP receptors in the brain to reduce migraine symptoms of headache, nausea, vomiting, light sensitivity, and sound sensitivity, and it also can be taken regularly prevent as many as episodic migraines from happening. 

Nurtec is an orally disintegrating tablet (ODT) that dissolves on the tongue or under the tongue, without the need to take it with a glass of water. Because Nurtec ODT dissolves in the mouth, it gets absorbed into the bloodstream very quickly.  Nurtec ODT starts working within one hour to relieve pain from migraine, and in 2 hours 59.3% of migraine patients had pain relief, according to clinical trials.

Nurtec ODT was first approved by the FDA on February 27, 2020.

What is Nurtec used for?

Nurtec is FDA approved to be used to treat adults with acute migraines that occur with or without aura, and it is also FDA approved for the preventive treatment of episodic migraine in adults.

Warnings

It is not known if it is safe to take Nurtec ODT for more than 15 migraine headaches in 30 days.

Nurtec ODT can be taken once a day as needed, to treat an acute migraine. You should not take more than 1 tablet in 24 hours. Nurtec ODT can be taken every second day to prevent episodic migraine. The safety of using more than 18 doses in a 30-day period has not been established.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking Nurtec ODT

Allergies: You should not take Nurtec ODT if you are:

• allergic to rimegepant or any of the other ingredients contained in the orally disintegrating tablets. See the end of this page for a complete list of ingredients.

Kidney or Liver disease: To make sure Nurtec is safe for you, tell your doctor if you have ever have or every had:

• liver disease; or
• kidney disease (or if you are on dialysis).

Age: Rimegepant is not approved for use by anyone younger than 18 years old.

Nurtec ODT and Pregnancy:

Tell your healthcare professional if you are pregnant or plan to become pregnant. It is not known if this medicine will harm your unborn baby. Having migraine headaches may cause complications during pregnancy such as dangerously high blood pressure (preeclampsia) that can lead to medical problems in both mother and baby. Your healthcare provider or doctor will help you decide whether the benefit of treating your migraine outweighs any risk to your baby.

There is a pregnancy exposure registry for women who take Nurtec ODT during pregnancy. The study is named MONITOR (Migraine Observational NURTEC Pregnancy Registry). A registry is a study. The purpose of this registry is to collect information about your health and the health of your baby. You may enroll yourself, or your healthcare provider can help you enroll in this registry.

Nurtec ODT and Breastfeeding:

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Very small amounts of this medicine will pass into your breast milk. Talk with your healthcare provider about the best way to feed your baby if you take Nurtec ODT.

How should I take Nurtec ODT?

Nurtec ODT comes as an orally disintegrating tablet (a tablet that dissolves quickly in the mouth) that is place under or onto the tongue to dissolve.

Remove the tablet from the package only when you are ready to take the medicine.

• It is important to have dry hands when opening the blister pack.

• Peel the foil covering from the blister and remove the tablet.  Do not try to push the orally disintegrating tablet through the foil packaging as you may damage it.
• Immediately place the tablet on or under your tongue. 
• The tablet will quickly dissolve and can be swallowed with saliva. No water is needed to swallow disintegrating tablets.
• Swallow several times as the tablet dissolves.

Use Nurtec ODT exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Call your doctor if your headaches do not get better or occur more frequently after taking this medicine

Dosing information

Acute treatment of migraine (with or without aura) when migraine occurs:

• One tablet (75mg) as needed when you have a migraine.
• Maximum of one tablet in a 24-hour period.
• The safety of using more than 18 doses in a 30-day period is currently not known.

Preventative treatment of episodic migraine:

• One tablet (75mg) every other day (every 48 hours)

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Nurtec ODT side effects

Nurtec ODT can cause an allergic reaction which can be serious. If you experience any of the following symptoms, you should immediately call your doctor or get emergency medical treatment:

• difficulty breathing
• shortness of breath
• swelling of the throat, tongue, mouth, lips, face or eyes
• hives
• rash
• Itching

An allergic reaction called delayed hypersensitivity reactions may occur days after you have taken this medicine and can be severe.

The most common side effect of Nurtec is nausea, when it is used for acute treatment of migraine attacks.

When Nurtec ODT is used as a preventive treatment of episodic migraine, its most common side effects are nausea, indigestion and stomach pain.

What is Qulipta?

Qulipta is used to help prevent episodic and chronic migraine headaches in adults. These are severe, throbbing headaches that sometimes are accompanied by nausea and sensitivity to sound or light. Qulipta is an oral tablet taken once a day.

Qulipta (atogepant) belongs to a class of medications called CGRP inhibitors. 

Qulipta gained FDA approval on September 28, 2021. There is no Qulipta generic available.

How does Qulipta work?

Qulipta’s mechanism of action involves blocking the effect of CGRP, a small protein that is highly prevalent in the sensory nerves that supply the head and neck. CGRP is involved in pain transmission, inflammation, and blood vessel dilation, and research has shown that levels of CGRP increase during a migraine attack. It may also play a causative role in the initiation of migraine attacks. By blocking CGRP, Qulipta helps prevent migraine headaches (see How does Qulipta work? for more information).

Clinical trials have shown that Qulipta starts working within the first week of treatment. Research also shows a 54% reduction in monthly migraine days in patients with episodic migraine and a 36% reduction in patients with chronic migraine headaches .

Side effects

The most common side effects of Qulipta are:

• nausea
• constipation
• feeling tired or sleepy.

Serious side effects and warnings

Qulipta may cause the following serious side effects:

• Allergic (hypersensitivity) reactions, including anaphylaxis. Serious allergic reactions can happen when you take Qulipta or days after. Stop taking Qulipta and get emergency medical help right away if you get any of the following symptoms, which may be part of a serious allergic reaction:
  • swelling of the face, lips, or tongue
  • itching
  • trouble breathing
  • hives
  • rash.
• High blood pressure: High blood pressure or worsening of high blood pressure can happen when you take Qulipta. Contact your healthcare provider if you have an increase in blood pressure.
• Raynaud’s phenomenon: This is a type of circulation problem that can worsen or happen when you take Qulipta. Raynaud’s phenomenon can lead to your fingers or toes feeling numb, cool, or painful, or changing color from pale to blue to red. Contact your healthcare provider if these symptoms occur.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects.

Before taking this medicine

Do not take Qulipta if you are allergic to atogepant, Qulipta, or any of the inactive ingredients in the tablets.

To make sure Qulipta is safe for you, tell your doctor if you have ever had:

• kidney disease (or if you are on dialysis)
• liver disease
• are pregnant or planning to become pregnant
• are breastfeeding or intend to breastfeed.

Qulipta is not approved for use by anyone younger than 18 years old.

Pregnancy

In animal trials, Qulipta caused pregnancy problems such as low birth weight or birth defects. It is not known if these effects could occur in humans. Ask your doctor about the risk.

Having migraine headaches during pregnancy may increase the risk of dangerously high blood pressure that can lead to medical problems in both mother and baby. The benefit of preventing migraines may outweigh any risk. Tell your doctor if you become pregnant.

Breastfeeding

Ask a doctor if it is safe to breastfeed while using this medicine.

How should I take Qulipta?

Take Qulipta exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

• Qulipta is usually taken 1 time daily.
• You may take Qulipta with or without food.
• The dosage of Qulipta depends on what other medications you are currently taking.

Qulipta dosing

Usual Qulipta Adult Dose for Episodic Migraine Prophylaxis:

• Qulipta 10 mg, 30 mg, or 60 mg orally once a day.
• The specific dosage depends on how often you get migraines.
• The dosage may need adjusting in severe liver or kidney disease and in those taking interacting medicines.

Usual Qulipta Adult Dose for Chronic Migraine Prophylaxis:

• Qulipta 60 mg orally once a day.

Qulipta dosage adjustments

Dosage adjustments are needed when Qulipta is taken with certain other medications and for people with severe kidney disease. The table below outlines the recommended Qulipta dosing modifications for drug interactions and specific populations.

Qulipta cost

The cost of Qulipta depends on your insurance and the pharmacy you use. With the Qulipta Complete Savings Card, eligible commercially insured patients may pay as little as $0.

This Qulipta co-pay assistance program is not available to patients receiving prescription reimbursement under Medicare [including Part D], Medicare Advantage, Medigap, Medicaid, TRICARE, Department of Defense, or Veterans Affairs programs, or where prohibited by law. Call 1-855-QULIPTA for additional information.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking Qulipta?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

What other drugs will affect Qulipta?

Tell your doctor about all your current medicines. Many drugs can affect atogepant, especially:

• cyclosporine;
• St. John’s wort;
• an antibiotic such as clarithromycin or rifampin;
• antifungal medicine such as itraconazole or ketoconazole;
• antiviral medicine to treat HIV, such as efavirenz or etravirine; or
• seizure medicine such as carbamazepine or phenytoin.

This list is not complete, and many other drugs may affect Qulipta. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Qulipta ingredients

Active ingredient: atogepant
Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, mannitol, microcrystalline cellulose, polyvinylpyrrolidone vinyl acetate copolymer, sodium chloride, sodium stearyl fumarate, and vitamin E polyethylene glycol succinate.

Qulipta is supplied as 10 mg, 30 mg, and 60 mg tablets.

Storage

Store Qulipta at room temperature away from moisture and heat.

Who makes Qulipta?

Qulipta (atogepant) is made by AbbVie, headquartered in North Chicago, Illinois.

Key medications in AbbVie’s portfolio include:

• Humira (arthritis, psoriasis)
• Botox (cosmetic and therapeutic uses)
• Vraylar (schizophrenia, bipolar)
• Rinvoq (arthritis)
• Skyrizi (psoriasis)
• Ubrelvy (migraine).

What is rimegepant?

Rimegepant is a prescription medicine used by adults to treat migraines (with or without aura) when they occur and also to prevent episodic migraines. Rimegepant works to reduce migraine symptoms of headache, nausea, vomiting, light sensitivity and sound sensitivity, by blocking CGRP receptors. This medicine may reduce the number of monthly migraine days when taken to prevent episodic migraines.

Rimegepant is an orally disintegrating tablet (ODT) that dissolves in the mouth without the need to take it with a glass of water. Because the tablet dissolves in the mouth it is absorbed into the bloodstream quickly, with the highest blood concentrations reached after one and a half hours.

Warnings

It is not known if it is safe to take rimegepant ODT for more than 15 migraine headaches in 30 days.

Rimegepant ODT can be taken 1 time each day as needed. You should not take more than 1 tablet in 24 hours.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

If you take too much rimegepant ODT, go to the nearest emergency room right away.

Before taking this medicine

You should not use rimegepant if you are allergic to it.

To make sure rimegepant is safe for you, tell your doctor if you have ever had:

• liver disease; or
• kidney disease (or if you are on dialysis).

It is not known whether rimegepant will harm an unborn baby. However, having migraine headaches may cause complications during pregnancy such as dangerously high blood pressure that can lead to medical problems in both mother and baby. The benefit of treating migraines may outweigh any risks to the baby.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Rimegepant is not approved for use by anyone younger than 18 years old.

How should I take rimegepant?

Use rimegepant ODT exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Call your doctor if your symptoms do not improve, or if you have more than 15 headaches in one month (30 days).

Remove an orally disintegrating tablet from the package only when you are ready to take the medicine.

• Use dry hands when opening the blister pack.
• Peel back the foil covering of one blister and gently remove the orally disintegrating tablet (ODT). Do not push the ODT through the foil.
• As soon as the blister is opened, remove the ODT and place on the tongue; alternatively, the ODT may be placed under the tongue.
• The ODT will disintegrate in saliva so that it can be swallowed without additional liquid.
• Swallow several times as the tablet dissolves.
• Take the ODT immediately after opening the blister pack. Do not store the ODT outside the blister pack for future use.

Store at cool room temperature, away from moisture and heat.

Dosing information

Usual Adult Dose for Migraine:

75 mg orally
Maximum dose: 75 mg in a 24-hour period

Comments:
-This drug is not for the preventive treatment of migraine.
-The safety of treating more than 15 migraines in a 30-day period is unknown.

Use: For the acute treatment of migraine with or without aura.

Place on tongue (or under tongue) and allow to disintegrate in saliva and swallow; additional liquid is not necessary. Do not take more than 1 dose in 24-hours.

What happens if I miss a dose?

Since rimegepant is used when needed, it does not have a daily dosing schedule. Call your doctor if your symptoms do not improve after using this medicine.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

Rimegepant side effects

Get emergency medical help if you have signs of an allergic reaction to rimegepant: hives, rash; difficult breathing; swelling of your face, lips, tongue, or throat.

An allergic reaction can be severe, and may occur days after you have taken this medicine.

What is Zavzpret?

Zavzpret (zavegepant) is a calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray used to treat acute migraine in adults. Zavzpret can begin relieving pain as early as 15 minutes, and after 2 hours, Zavzpret is significantly better than a placebo at relieving nausea, sensitivity to light (photophobia) or sensitivity to sound (phonophobia).

Zavzpret is not used for preventing migraines.

How does Zavzpret work?

CGRP is a chemical messenger that has a role in causing pain and other symptoms of migraines. Zavzpret is a small molecule CGRP receptor antagonist that works by blocking the CGRP receptors, which reduces migraine pain and other symptoms of migraine, including nausea and sensitivity to light and sound. 

Who should not take Zavzpret?

You should not take this medicine if you are allergic to the active ingredient, zavegepant, or any of the inactive ingredients.  here is a complete list of ingredients at the bottom of the page.

What should I tell my doctor before using Zavzpret?

Tell your healthcare provider about all of your medical conditions, including if you:

 • have kidney problems.

 • have liver problems. 

Pregnancy and Zavzpret 

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if this medicine will harm your unborn baby. 

Breastfeeding and Zavzpret 

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known whether this medicine passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby 

How should I take Zavzpret?

• Use this medicine exactly how your healthcare provider tells you to use it.
• Read all the printed instructions your doctor gives you.
• Zavzpret is a nasal spray
• Each dose of this medicine is provided in an individual pack. Use all of the medicine in 1 pack for a complete dose.
• Each Zavzpret only contains 1 time and cannot be reused.
• Do not test or prime the nasal spray before use. 
• Avoid using intranasal decongestants with this medicine.  If you have to use an intranasal decongestant, use it at least 1 hour after using this medicine. 

Dosing information

• The recommended dose is 10 mg given as a single spray in one nostril. 
• Do not use more than 1 spray (10 mg) of Zavzpret nasal spray in a 24-hour period.
•  It is not known if it is safe to use more than 8 sprays (doses) of this medicine in 30 days. 

What are the side effects of Zavzpret?

Common Zavzpret side effects may include:

• unusual taste (dysgeusia)
• feeling sick (nausea)
• nasal discomfort
• vomiting .

Serious Zavzpret side effects include:

Allergic reactions, including hives and swelling of the face, can happen after you use this medicine. Call your healthcare provider or get emergency help right away if you have any of the following symptoms, which may be part of an allergic reaction: 

• swelling of the face, mouth, tongue, or throat 
• trouble breathing

These are not the only possible side effects of this medicine. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800- FDA-1088.

Interactions

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.  

Storage

• Store Zavzpret in the blister package that it comes in.
•  Store at room temperature between 68°F to 77°F (20°C to 25°C).
• Do not freeze.
• Keep this medicine and all medicines out of the reach of children. 

Ingredients

Active ingredients: zavegepant 

Inactive ingredients: dextrose, hydrochloric acid, sodium hydroxide, and succinic acid in water for injection. 

Manufacturer:

Pfizer Labs, Division of Pfizer Inc. New York, NY 10001.

What is Ajovy?

Ajovy is an injectable prescription medicine used to prevent migraine headaches in adults.

Ajovy works by blocking the activity of calcitonin gene-related peptide (CGRP).

Ajovy may also be used for purposes not listed in this medication guide.

Warnings

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

You should not use Ajovy if you are allergic to fremanezumab-vfrm.

Ajovy is not approved for use by anyone younger than 18 years old.

Tell your doctor if you are pregnant. It is not known whether this medicine will harm an unborn baby. However, having migraines during pregnancy may cause complications such as preeclampsia (which can lead to medical problems in both mother and baby). The benefit of preventing migraines may outweigh any risks to the baby.

It may not be safe to breast-feed while using fremanezumab-vfrm. Ask your doctor about any risk.

How should I use Ajovy?

Use Ajovy injection exactly as it was prescribed. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Ajovy is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself.

Ajovy is usually given as 1 injection once a month, or as 3 injections (in separate syringes) once every 3 months.

Read and carefully follow any Instructions for Use provided with your medicine. Do not use fremanezumab-vfrm if you don’t understand all instructions for proper use. Ask your doctor or pharmacist if you have questions.

Prepare your injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, is frozen, or has particles in it. Call your pharmacist for new medicine.

Store Ajovy in the original carton in a refrigerator, protected from light. Do not freeze or shake this medicine.

Take the medicine out of the refrigerator and let it reach room temperature for 30 minutes before injecting your dose. Do not warm the medicine with hot water, sunlight, or a microwave.

You may also store Ajovy in the original carton at room temperature for up to 7 days. Throw the medicine away if it has been at room temperature for 7 days or longer

Each single-use prefilled autoinjector or syringe is for one use only. Throw it away after one use, even if there is still medicine left inside.

Use a needle and syringe only once and then place them in a puncture-proof “sharps” container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Dosing information

Usual Adult Dose for Migraine Prophylaxis:

225 mg subcutaneously once a month
-Alternatively, 675 mg subcutaneously may be administered once every 3 months

Comments:
-To administer 675 mg subcutaneously, 3 consecutive subcutaneous injections of 225 mg are given.
-If switching dosage options, administer the first dose of the new regimen on the next scheduled date of administration.

Use: For the preventive treatment of migraine.

What happens if I miss a dose?

Use the medicine as soon as you remember, and then restart your regular injection schedule 1 month or 3 months later.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while using Ajovy?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

Ajovy side effects

Get emergency medical help if you have signs of an allergic reaction to Ajovy: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

An allergic reaction to fremanezumab-vfrm can occur up to 1 month after an injection.

Common Ajovy side effects may include:

• pain, redness, or a hard lump where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Ajovy?

Other drugs may interact with fremanezumab-vfrm, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Ajovy Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Ajovy.Ajovy (fremanezumab-vfrm) – Teva Branded Pharmaceutical Products R&D, Inc.

What is Vyepti?

Vyepti (eptinezumab-jjmr) is used to prevent migraines and is given as an IV infusion every 3 months (four times a year). Vyepti infusion helps reduce monthly migraine days for chronic migraines and episodic migraines in adults so that you may have more migraine-free days. 

Vyepti infusion works by blocking a protein called calcitonin gene-related peptide (CGRP), which is involved in migraines. CGRP levels increase during a migraine attack and may also be involved in the start of a migraine. It is thought that by blocking CGRP, Vyepti reduces monthly migraine days.

Vyetpi infusion received FDA approval on February 22, 2020.

Vyepti side effects

The most common Vyepti side effects are stuffy nose, scratchy throat, and allergic reactions.

Serious Vyepti side effects are allergic reactions. Allergic reactions can happen after receiving Vyepti. Call your healthcare provider or get emergency medical help right away if you have any of the following symptoms of an allergic reaction:

• rash
• swelling of your face, lips, tongue or throat
• trouble breathing
• hives
• redness in your face

These are not all of the possible side effects of Vyepti infusion. Ask your pharmacist or healthcare provider for more information. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Who should not receive Vyepti?

Before using this medicine, tell your healthcare professional about all of your medical conditions.

You should not receive Vyepti infusion if you are allergic to the active ingredient eptinezumab-jjmr or any of the ingredients in Vyepti. See the end of this page for a complete list of ingredients.

Pregnancy

Tell your healthcare provider if you are pregnant, plan to become pregnant, or become pregnant, as it is not known if Vyepti infusion will harm your unborn baby.

There is a pregnancy registry for women who take Vyepti. The purpose of this registry is to collect information about your and your baby’s health. You may enroll yourself by calling 1-855-810-8549 or talk to your healthcare provider about how you can participate in this registry.

Breastfeeding

Tell your healthcare provider if you are breastfeeding or planning to breastfeed, as it is not known if Vyepti passes into your breast milk. Talk to your healthcare professional about the best way to feed your baby while using this medicine.

How will I receive Vyepti?

• Vyepti is given by intravenous (IV) infusion in your vein by a healthcare provider in a healthcare setting.
• Vyepti infusions take approximately 30 minutes and are given every 3 months.

If you have questions about your infusion schedule, ask your healthcare provider.

Vyepti Dosage Information

The recommended Vyepti dosage is 100mg IV infusion every 3 months. Some patients may benefit from a 300 mg intravenous infusion every 3 months.

Dilution Instructions

Vyepti requires dilution prior to administration. Dilute only in 100 mL 0.9% Sodium Chloride Injection, USP. The infusion bags must be made of polyvinyl chloride (PVC), polyethylene (PE), or polyolefin (PO). Use appropriate aseptic technique when preparing Vyepti solution for intravenous infusion. Vyepti single-dose vials contain no preservative; discard the unused portion remaining in the vial.

Vyepti is available as: 100 mg/mL solution in a single-dose vial which needs to be diluted.

Dilution for 100 mg dose:

To prepare the solution, withdraw 1 mL of Vyepti from a single-dose vial using a sterile needle and syringe. Inject the 1 mL content into a 100 mL bag of 0.9% Sodium Chloride Injection, USP.

Dilution for 300 mg dose:

To prepare the solution, withdraw 1 mL of Vyepti from each of 3 single-dose vials using a sterile needle and syringe. Inject the resulting 3 mL content into a 100 mL bag of 0.9% Sodium Chloride Injection, USP.

Storage and Handling of Diluted Product

Gently invert the Vyepti solution to mix completely. Do not shake. Following dilution, Vyepti solution must be infused within 8 hours. During this time, solution should be stored at room temperature, 20°C to 25°C (68°F to 77°F). Do not freeze.

What are the ingredients in Vyepti?

Active ingredient: eptinezumab-jjmr

Inactive ingredients: L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sorbitol, and Water for Injection.
The vial stopper is not made with natural rubber latex.

Storage

Store a single-dose vial at 2°C to 8°C (36°F to 46°F) in the original carton to protect it from light until the time of use. Do not freeze or shake.

Store diluted solution at 0°C to 25°C (68°F to 77°F). Do not freeze. Diluted solution must be infused within 8 hours

Company

Manufactured by: Lundbeck Seattle BioPharmaceuticals, Inc., 11804 North Creek Parkway South, Bothell, WA 98011

Vyepti Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Vyepti.Vyepti (eptinezumab-jjmr) – Lundbeck Seattle BioPharmaceuticals, Inc.

What is Aimovig?

Aimovig (erenumab-aooe) is a once-monthly, self-administered injection used to prevent migraines in adults. It helps prevent migraines before they start and reduces the number of migraine days per month. Aimovig is given as an injection under the skin (subcutaneous injection) using a single-dose prefilled SureClick® autoinjector or a single-dose prefilled syringe.

Aimovig works by blocking the effect of calcitonin gene-related peptide (CGRP), a small protein involved in migraines that increases during a migraine attack. By blocking CGRP, Aimovig stops interaction between CGRP and the CGRP receptor which helps to prevent migraines. Aimovig is from a class of medicines called CGRP inhibitors. 

Aimovig FDA approval was granted on May 17, 2018, for Amgen Inc. There is no generic available.

Aimovig side effects

Common Aimovig side effects

The most common Aimovig side effects include:

• pain, redness, or swelling at the injection site (6%)
• constipation (1%)
• cramps, muscle spasms (<1%).

These common side effects are for the 70mg dose.

Serious Aimovig side effects

Aimovig may cause serious side effects, including:

• Allergic reactions, including a rash or swelling. This can happen within hours to days after using the medicine. Call your healthcare provider or get emergency medical help right away if you have any of the following symptoms of an allergic reaction: hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.
• Severe constipation. In some cases, people have been hospitalized or needed surgery. Contact your healthcare provider if you have severe constipation or constipation associated with symptoms such as severe or constant belly pain, vomiting, swelling of the belly, or bloating.
• High blood pressure or worsening of high blood pressure. Ask your healthcare provider to monitor your blood pressure or call them immediately if you develop severe headaches, blurred vision, or pounding in your neck or ears.

High blood pressure or constipation are possible long-term side effects of this medicine.

Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects of this injection. Ask your pharmacist or doctor for more information. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Amgen at 1-800-77-AMGEN (1-800-772-6436).

Warnings

Aimovig may cause allergic reactions. If a serious allergic reaction occurs, stop injecting and go to the emergency room. Hypersensitivity reactions can occur within hours to more than one week after administration.

May also cause constipation with serious complications and new-onset or worsening of pre-existing high blood pressure may occur.

Before you inject this medicine, always check the label of your single-dose prefilled autoinjector or single-dose prefilled syringe to make sure you have the correct medicine and the correct dose.

Aimovig does not treat an acute migraine (one that is happening right now).

Aimovig cost

The cost of Aimovig varies depending on your insurance plan and which pharmacy you use. Refer to our price guide page for more information about cost.

You may also be eligible for an Aimovig coupon, an access card, or an Aimovig copay card.

Do insurance cover Aimovig?

Yes, insurance may cover Aimovig, this will depend on your insurance company and the details of your insurance policy.

Before taking this medicine

You should not use this medicine if you are allergic to erenumab, Aimovig, or any of the inactive ingredients in the injection.

Before you start using this injection, tell your doctor about all your medical conditions, including if you are:

• Pregnant or plan to become pregnant
• Breastfeeding or plan to breastfeed.

Pregnancy

It is not known if Aimovig will harm your unborn baby. However, having migraine headaches during pregnancy may cause complications such as preeclampsia (dangerously high blood pressure that can lead to medical problems in both mother and baby). The benefit of preventing migraines may outweigh any risks to the baby.

There is a pregnancy registry for women who take Aimovig. The purpose of this registry is to collect information about your health and your baby’s health. You may enroll yourself by calling 1-833-244-4083 or visiting https://www.genesispregnancyregistry.com/. Or you may talk to your doctor about how you can take part in this registry.

Breastfeeding

It is not known if this medicine passes into your breast milk. It may not be safe to breastfeed while using this medicine. Ask your doctor about any risks.

Talk to your healthcare provider about the best way to feed your baby while using this medicine.

How should I use Aimovig?

Use Aimovig exactly as directed by your healthcare provider. Follow all directions on your prescription label and read all medication guides or instruction sheets.

• Aimovig comes in 2 different types of devices: a single-dose (1-time) prefilled autoinjector or a single-dose (1-time) prefilled syringe. Your healthcare provider will prescribe the type and dose that is best for you.
• Aimovig is injected under your skin (subcutaneously) once a month. Do not inject it yourself until a healthcare provider has shown you how to do so.

Take the injection out of the refrigerator and allow it to warm up to room temperature for 30 minutes before injecting it. Protect from sunlight. Do not heat the medicine in hot water or a microwave. Do not use it if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

• Inject it subcutaneously (under the skin) of the abdomen (but not within 2 inches of the belly button), thigh, or upper arm.
• Each single-use prefilled syringe or autoinjector is for one use only. Throw it away after one use, even if there is still medicine left inside.
• Do not shake the syringe or autoinjector or you may ruin the medicine.

Only use the form and strength your doctor prescribes.

Use a needle and syringe only once and then place them in a puncture-proof “sharps” container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Aimovig dosage

Usual Aimovig dose is 70mg once a month.

Some people may benefit from a dosage of 140mg. Aimovig 140mg is taken once a month.

Aimovig formulations 

• Aimovig autoinjector 70 mg/mL in a single-dose prefilled SureClick autoinjector
• Aimovig injection 70 mg/mL solution in a single-dose prefilled syringe
• Aimovig autoinjector 140 mg/mL solution in a single-dose prefilled SureClick autoinjector
• Aimovig injection 140 mg/mL solution in a single-dose prefilled syringe.

What happens if I miss a dose?

If you forget to take your dose or are not able to take the dose at the regular time, take your missed dose as soon as you remember. After that, you can continue to take Aimovig one time each month from the date of your last dose.

What should I avoid while using this medicine?

Avoid injecting this medicine into skin that is red, bruised, tender, or hard.

What other drugs will affect this medicine?

Other drugs may interact with Aimovig, including prescription and over-the-counter medicines, vitamins, and herbal products.

Tell your pharmacist or healthcare provider about all the medicines you take, including any prescription and over-the-counter medicines, vitamins, or herbal supplements. See the prescribing information for a full list of interactions.

Does Aimovig interact with my other drugs?

Enter medications to view a detailed interaction report using our Drug Interaction Checker.Drug nameAdd a drug to check interactionsAdd

Storage

Store Aimovig in the refrigerator between 36°F to 46°F (2°C to 8°C).

• After removing from the refrigerator, it can be stored at room temperature between 68°F to 77°F (20°C to 25°C) for up to 7 days.
• Throw away the medicine if kept at room temperature for more than 7 days.
• Keep it in the original carton. This will protect the medicine from light.
• Do not freeze. Do not shake.
• Keep out of the reach of children.

Ingredients

Active: erenumab-aooe

Inactive: acetate, polysorbate 80, and sucrose

Manufacturer

Aimovig Amgen Inc., One Amgen Center Drive Thousand Oaks, CA U.S.A. 

Aimovig Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Aimovig.

What is Ubrelvy?

Ubrelvy tablets are used to treat migraine headaches in adults, that are with or without aura. Ubrelvy works by blocking a protein called CGRP in the nerve endings that are involved in pain and migraines, this helps reduce pain and migraine symptoms. Ubrelvy is from the CGRP inhibitor class of medicines and is a prescription medicine.

Ubrelvy is used when you have a migraine headache, it is not used to prevent a migraine headache.

Ubrelvy (ubrogepant) received FDA approval on December 23, 2019, for the acute treatment of migraine with or without aura in adults. They are available as Ubrelvy 100mg tablets and Ubrelvy 50mg tablets.

Ubrelvy side effects

Common Ubrelvy side effects may include nausea or sleepiness.

Serious Ubrelvy side effects Get emergency medical help if you have signs of an allergic reaction to Ubrelvy: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Warnings

You should not take Ubrelvy if you are taking medicines known as strong CYP3A4 Inhibitors, such as:

• ketoconazole
• clarithromycin
• itraconazole

Ask your healthcare provider if you are not sure if you are taking any of these medicines. Your healthcare provider can tell you if it is safe to take Ubrelvy with other medicines.

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

Before taking this medicine

Many drugs can interact and cause dangerous effects. Some drugs should not be used together with Ubrelvy. Your doctor may change your treatment plan if you also use:

• nefazodone;
• an antibiotic – clarithromycin, telithromycin;
• antifungal medicine – itraconazole, ketoconazole; or
• antiviral medicine to treat HIV/AIDS – indinavir, nelfinavir, ritonavir, saquinavir.

To make sure this medicine is safe for you, tell your doctor if you have:

• liver disease; or
• kidney disease.

Ubrelvy is not approved for use by anyone younger than 18 years old.

Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether Ubrelvy will harm an unborn baby. However, having migraine headaches during pregnancy may cause complications such as diabetes or eclampsia (dangerously high blood pressure that can lead to medical problems in both mother and baby). The benefit of treating migraines may outweigh any risks to the baby.

Breastfeeding

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risks.

How should I take Ubrelvy?

Take Ubrelvy exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You may take this medicine with or without food. Avoid grapefruit or grapefruit juice.

After taking Ubrelvy: If your headache does not completely go away or goes away and comes back, you may take a second tablet if it has been at least 2 hours since your first dose. If your symptoms have not improved, contact your doctor before taking any more tablets.

You should not take a second tablet within 24 hours if you have consumed a grapefruit product or if you also take any of the following medications:

• ciprofloxacin;
• cyclosporine;
• fluconazole;
• fluvoxamine; or
• verapamil.

Call your doctor if you have more than 8 headaches in one month (30 days). Tell your doctor if this medicine seems to stop working as well in treating your migraine attacks.

What is the cost of Ubrelvy?

The cost of prescription drugs varies depending on your insurance plan and which pharmacy you use. Refer to our Ubrelvy price guide page for more information about the cost.

You may also be eligible for a Ubrelvy savings card, Ubrelvy coupon or Ubrelvy copay card. Ask your doctor or pharmacist if you qualify.

Ubrelvy Dosing information

Usual Adult Dose for Migraine: Take 50 mg to 100 mg orally once, then after 2 hours, a second dose may be taken if needed.
Maximum dose: 200 mg in a 24-hour period

Comments: The safety of treating more than 8 migraines in a 30-day period is unknown.

What happens if I miss a dose?

Since Ubrelvy is used when needed, it does not have a daily dosing schedule. Do not take more than 200 milligrams in a 24-hour period. Do not use this medicine to treat more than 8 headaches per month.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line

What to avoid

Grapefruit may interact with ubrogepant and lead to unwanted side effects. You should not take a second Ubrelvy tablet within 24 hours after consuming grapefruit or grapefruit juice.

What other drugs will affect Ubrelvy?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your current medicines. Many drugs can interact with Ubrelvy, especially:

• curcumin (also called turmeric);
• cyclosporine;
• eltrombopag;
• fluconazole;
• fluvoxamine;
• phenytoin;
• St. John’s wort;
• an antibiotic – ciprofloxacin, rifampin;
• a barbiturate – butabarbital, phenobarbital, secobarbital; or
• heart or blood pressure medicine – carvedilol, quinidine, verapamil.

This list is not complete and many Other drugs may interact with ubrogepant. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Ubrelvy Package Insert

Review the full Ubrelvy prescribing information here for more detailed information about this medicine. Discuss any medical questions you have with your doctor or other health care provider. This is not all the information you need to know about Ubrelvy for safe and effective use and does not take the place of talking to your doctor about your treatment.

Storage

Store at room temperature between 68ºF to 77ºF (20ºC to 25ºC).

Ingredients

Active ingredient: ubrogepant

Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, mannitol, microcrystalline cellulose, polyvinylpyrrolidone vinyl acetate copolymer, sodium chloride, sodium stearyl fumarate, and vitamin E polyethylene glycol succinate.

Company

Manufactured for: AbbVie Inc. North Chicago, IL 60064