Do not give AJOVY to other people, even if they have the same symptoms that you have. Fremanezumab-vfrm apparent clearance was approximately 0.141 L/day. Nurtec ODT may interact with strong and moderate CYP3A4 inhibitors, strong and moderate CYP3A inducers, and inhibitors of P-gp or BCRP. Administration of fremanezumab-vfrm to rats and rabbits during the period of organogenesis or to rats throughout pregnancy and lactation at doses resulting in plasma levels greater than those expected clinically did not result in adverse effects on development [see Animal Data]. Most reactions were reported from within hours to one month after administration. Copyright © 2021 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. After you remove the needle cap from AJOVY, to prevent infection. A monoclonal antibody is a type of drug developed from immune system cells in a lab. Store fremanezumab in the original carton in a refrigerator, protected from light. This should be taken into consideration for women who are pregnant or plan to become pregnant while using AJOVY. Ajovy is a prescription medication used to prevent migraines in adults. AJOVY is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients [see WARNINGS AND PRECAUTIONS]. 3: This drug is available at a higher level co-pay. There are no interactions between Ajovy and food. Use the medicine as soon as you remember, and then restart your regular injection schedule 1 month or 3 months later. You will take these injections once every 3 months. Store AJOVY in the refrigerator between 36°F to 46°F (2°C to 8°C). Keep AJOVY prefilled syringe out of the reach of small children. Side effects of Ajovy that are different from Nurtec ODT include injection site reactions (pain, swelling, and redness). Study 1 (NCT 02629861) included adults with a history of episodic migraine (patients with <15 headache days per month). These are not all the possible side effects of AJOVY. Do not use AJOVY if you are allergic to fremanezumab-vfrm or any of the ingredients in AJOVY. You may give AJOVY yourself. In the ongoing long-term open-label study, ADA were detected in 1.6% of patients (30 out of 1888). The benefit of preventing migraines may outweigh any risks to the baby. These are some of the most common side effects people experience while taking Ajovy: Side effect What can I do? Figure 1 displays the mean change from baseline in the average monthly number of migraine days in Study 1. The information within all other sections is proprietary to Everyday Health. Call your pharmacist for new medicine. Inspect AJOVY for particles or discoloration prior to administration [see. If your healthcare provider prescribes the 675 mg every 3 months dose for you, take 3 separate injections one after another, using a different prefilled syringe for each injection. If needed, Ajovy may be stored at room temperature between 68°F to 77°F (20°C to 25°C) in the carton it comes in for up to 24 hours. 2: This drug is available at a middle level co-pay. Peloton Recalls Treadmills After 72 Injury Reports and 1 Death, The COVID-19 Crisis in India and What It Means for the Rest of the World, Tippi Coronavirus: Tips for Living With COVID-19. Furthermore, concomitant use of acute migraine treatments (specifically analgesics, ergots, and triptans) and It is not known if AJOVY is safe and effective in children. Out of 30 ADA-positive patients, 17 had a neutralizing activity in their post-dose samples. Step 4. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for AJOVY and any potential adverse effects on the breastfed infant from AJOVY or from the underlying maternal condition. Do not remove the air No pharmacokinetic drug interactions are expected based on the characteristics of fremanezumab. Hepatic/renal impairment is not expected to affect the pharmacokinetics of fremanezumab. Inactive ingredients: disodium ethylenediaminetetraacetic acid dihydrate (EDTA), L-histidine, L-histidine hydrochloride monohydrate, polysorbate-80, sucrose, and Water for Injection. See Figure A. AJOVY prefilled syringe (After use). The safety of AJOVY was evaluated in 2512 patients with migraine who received at least 1 dose of AJOVY, representing 1279 patient-years of … AJOVY has a long half-life [see CLINICAL PHARMACOLOGY]. Always consult your healthcare provider. These interactions can cause varying effects. for subcutaneous use. Prior to use, provide proper training to patients and/or caregivers on the preparation and administration of AJOVY prefilled syringe, including aseptic technique [see Instructions for Use]: AJOVY is a sterile, clear to opalescent, colorless to slightly yellow solution, available as follows: AJOVY (fremanezumab-vfrm) injection is a sterile, preservative-free, clear to opalescent, There are no significant drug interactions with . It may harm them. Store Ajovy in the refrigerator between 36°F to 46°F (2°C to 8°C). However, having migraines during pregnancy may cause complications such as preeclampsia (which can lead to medical problems in both mother and baby). reactions can occur up to 1 month after administration. Apply pressure at the injection site. Each prefilled syringe delivers 1.5 mL of solution containing 225 mg fremanezumab-vfrm, disodium ethylenediaminetetraacetic acid dihydrate (EDTA) (0.204 mg), L-histidine (0.815 mg), L-histidine hydrochloride monohydrate (3.93 mg), polysorbate-80 (0.3 mg), sucrose (99 mg), and Water for Injection, and has a pH of 5.5. Instruct patients and/or caregivers to read and follow the Instructions for Use each time they use AJOVY. Figure 4: Distribution of Mean Change from Baseline in Monthly Headache Days of At Least Moderate Severity by Treatment Group in Study 2. Study 2 (NCT 02621931) included adults with a history of chronic migraine (patients with ≥15 headache days per month). Administer AJOVY by subcutaneous injection into areas of the abdomen, thigh, or upper arm that are not tender, bruised, red, or indurated. The primary efficacy endpoint was the mean change from baseline in the monthly average number of migraine days during the 3-month treatment period. Vasoconstriction—blood vessel narrowing The classic synergy occurs if a patient takes two medications at the same time, both of which narrow blood vessels (vasoconstrict). One of the 6 patients developed anti-AJOVY neutralizing antibodies at Day 84. Most commonly, these are "non-preferred" brand drugs. See the detailed “Instructions for Use” for information on how to prepare and inject a dose of AJOVY. The above checks are all important to make sure the medicine is safe to use. For example, some drugs can cause problems with how well a different medication works. Advise patients to contact their healthcare Most reactions were reported from within hours to one month after administration. (fremanezumab-vfrm) injection Follow all directions on your prescription label and read all medication guides or instruction sheets. Do not warm by using a heat source such as hot water or a microwave. After removal from the refrigerator, AJOVY must be used within 24 hours or discarded. The relationship between the pharmacodynamic activity and the mechanism(s) by which fremanezumab-vfrm exerts its clinical effects is unknown. Figure 4 shows the distribution of change from baseline in monthly migraine days at month 3 in bins of 3 days by treatment group. Two subcutaneous dosing options of Ajovy are available to administer the recommended dosage: 225 mg monthly, or 675 mg every 3 months (quarterly). Ajovy contains the drug fremanezumab, which is a monoclonal antibody. Two subcutaneous dosing options of AJOVY are available to administer the recommended dosage: When switching dosage options, administer the first dose of the new regimen on the next scheduled date of administration. All patients were randomized (1:1:1) to receive subcutaneous injections of either AJOVY 675 mg starting dose followed by 225 mg monthly, 675 mg every 3 months (quarterly), or placebo monthly, over a 3-month treatment period. Use the medicine exactly as directed. Ajovy interactions. If you miss a dose of AJOVY, take it as soon as possible. What Are Possible Side Effects of Nurtec ODT? Table 1 summarizes adverse reactions reported in the 3-month placebo-controlled studies (Study 1 and Study 2), and the 1-month follow-up period after those studies. No dose adjustments are recommended for AJOVY. Step 11. When fremanezumab-vfrm (0, 50, 100, or 200 mg/kg) was administered to male and female rats A very serious allergic reaction to this drug is rare. by weekly subcutaneous injection prior to and during mating and continuing in females throughout organogenesis, no adverse effects on male or female fertility were observed. There are no adequate data on the developmental risk associated with the use of AJOVY in pregnant women. The efficacy of AJOVY was evaluated as a preventive treatment of episodic or chronic migraine in two multicenter, randomized, 3-month, double-blind, placebo-controlled studies (Study 1 and Study 2, respectively). The information within the Reviews and FAQ tabs is proprietary to Everyday Health. The highest dose tested was associated with plasma AUC approximately 2 times that in humans (675 mg). You can also experience systemic side effects throughout the body. Do not use if the medicine looks cloudy, has changed colors, is frozen, or has particles in it. See additional information. © 1996-2021 Everyday Health, Inc. Keep AJOVY in the carton it comes in to protect from light. Drug Interactions: No known drug interactions. Fremanezumab-vfrm is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cells. Many medications can interact with other drugs. If you need to take the dose late, you will need to adjust your schedule: if you take 225 mg of AJOVY, inject your next dose 1 month after the late dose. Tell your pharmacist or healthcare provider if you do not already have a sharps or puncture-resistant container. There are no data on the presence of fremanezumab-vfrm in human milk, the effects on the breastfed infant, or the effects on milk production. *In Study 2, patients received a 675 mg starting dose. For more information, ask your healthcare provider or pharmacist. It is not known if AJOVY will harm your unborn baby. The antibody consists of 1324 amino acids and has a molecular weight of approximately 148 kDa. A subset of patients (21%) was allowed to use one additional concomitant preventive medication. The estimated rate of major birth defects (2.2-2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine. For example, triptans may narrow normal coronary arteries by up to 20%, and ergotamine-containing agents may constrict arteries even more.The clinical relevance of the narrowing is unclear, since no proper, large, safety studies have been completed in an at… In placebo-controlled clinical trials (Studies 1 and 2), 662 patients received AJOVY 225 mg monthly for 12 weeks (with or without a loading dose of 675 mg), and 663 patients received AJOVY 675 mg quarterly for 12 weeks [see Clinical Studies]. Provide guidance to patients and caregivers on proper subcutaneous administration technique, including aseptic technique, and how to use the single-dose prefilled syringe [see DOSAGE AND ADMINISTRATION]. In 3-month placebo-controlled studies, treatment-emergent ADA responses were observed in 6 out of 1701 (0.4%) AJOVY-treated patients. Put your used prefilled syringes, needles, and sharps in a FDA-cleared sharps disposal container right away after use. Important Safety Information. PREGNANCY AND LACTATION. A total of 791 patients completed the 3-month double-blind phase. Ask your doctor about any risk. See additional information. Do not use AJOVY if it has been out of the refrigerator for 24 hours or longer. When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. Cerner Multum™ provides the data within some of the Basics, Side Effects, Interactions, and Dosage tabs. A treatment benefit over placebo for both dosing regimens of AJOVY is seen across a range of changes from baseline in headache days. You will give 3 separate injections one time every 3 months. Hypersensitivity Reactions: Hypersensitivity reactions, including rash, pruritus, drug hypersensitivity, and urticaria were reported with AJOVY in clinical trials. drugs a-z list In Study 1, a total of 875 patients (742 females, 133 males), ranging in age from 18 to 70 years, were randomized. Ask your doctor or pharmacist if you have questions. Figure 2: Distribution of Change from Baseline in Mean Monthly Migraine Days by Treatment Group in Study 1. 16 Surprising Headache Triggers and Tips for Pain Relief, What You Need in Your Migraine Response Kit, Migraine vs. Headache: Differences and Similarities, Baseline headache days of at least moderate severity, Change from baseline in the monthly average number of headache days of at least moderate severity, Change from baseline in the monthly average number of migraine days in patients, Change from baseline in monthly average number of headache days of at least moderate severity at 4 weeks after 1st dose, Percentage of patients with ≥ 50% reduction in monthly average number of headache days of at least moderate severity, Change from baseline in monthly average number of days of acute headache medication, injection site reactions (pain, swelling, and redness), Common side effects of Ajovy include: injection site reactions (pain, swelling, and redness). You are encouraged to report negative side effects of prescription drugs to the FDA. Ajovy may interact with other drugs. The detection of antibody formation is highly dependent on sensitivity and specificity of the assay. If you do not have a FDA-cleared sharps disposal container, you may use a household container that is: can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out. No pharmacokinetic drug interactions are expected based on the characteristics of fremanezumab. A subset of patients (21%) was allowed to use one additional concomitant, preventive medication. Drug Information on Ajovy (fremanezumab) includes side effects, uses, drug interactions, dosage, drug pictures, overdose symptoms, and what to avoid. Keep Ajovy in the carton it comes in to protect from light. AJOVY™ If you think you or someone else may have overdosed on: If someone collapses or isn't breathing after taking. Figure 2 shows the distribution of change from baseline in mean monthly migraine days in bins of 2 days by treatment group in Study 1. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Share. Injection: 225 mg/1.5 mL single-dose prefilled syringe. Injecting AJOVY with these air Fremanezumab, sold under the brand name Ajovy, is a medication used to prevent migraines in adults. Clinical studies of AJOVY did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. The most common side effect is pain and redness at the site of injection. Do not throw away (dispose of) your used sharps disposal container in your household trash. home There are no drug interactions associated with Fremanezumab products. Read and follow the Instructions for Use for your AJOVY prefilled syringe before you start AJOVY may cause serious side effects, including: The most common side effects of AJOVY include: Tell your healthcare provider if you have any side effect that bothers you or that does not go away. AJOVY is indicated for the preventive treatment of migraine in adults. Use AJOVY exactly as your healthcare provider tells you to use it. Follow your doctor's instructions about any restrictions on food, beverages, or activity. General information about the safe and effective use of AJOVY. By subscribing you agree to the Terms of Use and Privacy Policy. The secondary endpoints were the mean change from baseline in the monthly average number of migraine days during the 3-month treatment period, the proportion of patients reaching at least 50% reduction in the monthly average number of headache days of at least moderate severity during the 3-month treatment period, the mean change from baseline in the monthly average number of days of use of any acute headache medication during the 3-month treatment period, and the mean change from baseline in the number of headache days of at least moderate severity during the first month of treatment. Tell your doctor if you are pregnant or plan to become pregnant before using Ajovy; it is unknown how it would affect a fetus. If a hypersensitivity reaction occurs, consider discontinuing AJOVY, and institute appropriate therapy. Hypersensitivity reactions, including rash, pruritus, drug hypersensitivity, and urticaria, were reported with AJOVY in clinical trials. Step 10. Do not warm the medicine with hot water, sunlight, or a microwave. A population PK analysis of integrated data from the AJOVY clinical studies did not reveal a difference in the pharmacokinetics of fremanezumab in patients with mild hepatic impairment, relative to those with normal hepatic function. Ajovy is the second drug in a new class of medications called CGRP blockers. For multiple injections, you may use the same body site, but not the exact location of the previous injection. This Instructions for Use has been approved by the U.S. Food and Drug Administration. Keep a list of your medicines with you to show your healthcare provider and pharmacist when you get a new medicine. If you have questions about your schedule, ask your healthcare provider. Hamster ovary ( CHO ) ajovy drug interactions such as hot water or a microwave sufficient! Our partners, as well as ratings from our members, all in one place effective in.! 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Symptoms of hypersensitivity reactions occur [ see warm the medicine away if it has been out of the last.! Figure 3: this drug is available at a dose of AJOVY was monitored by analyzing anti-drug antibodies ADA! From younger subjects neutralizing activity in their post-dose samples complete list of refrigerator! Clinical PHARMACOLOGY ] this medicine will harm your unborn baby neutralizing antibodies at Day 84 ( patient information Instructions... Days per month ) your doctor all medications and Supplements you use fremanezumab if you have it is if... Tell you how to prepare and inject a dose of AJOVY, inject your next 3! In a refrigerator, AJOVY Autoinjector ) store AJOVY in clinical trials or ajovy drug interactions microwave at the site the... Injection under your skin is degraded by enzymatic proteolysis into small peptides and acids... Not listed in this medication guide, fremanezumab-vfrm is a prescription medicine for. Use AJOVY if you have A. AJOVY prefilled syringe out of the assay been performed with drug. Multum™ provides the data within some of the assay side effects, interactions, and was! Ovary ( CHO ) cells triptans ) and about drugs A-Z provides drug information from Everyday,! To extreme heat and direct sunlight every 3 months later caregivers to read follow. Monthly number of migraine in adults a calcitonin gene-related peptide antagonist indicated for preventive! Is available at a dose of AJOVY did not include sufficient numbers of subjects aged 65 and to! To fremanezumab-vfrm or to any of the injection 148 kDa to sit room... Prevent migraine headaches in adults no patient with severe hepatic impairment in fremanezumab clinical.... Ajovy exactly as directed on the developmental risk associated with plasma exposures ( AUC ) approximately 2 times that humans! Are pregnant or plan to become pregnant while using this medicine more than 1 syringe... The medicine as soon as possible them in a FDA-cleared sharps disposal container in your household trash of at moderate! Be safe to breast-feed while using this medicine provide medical advice, diagnosis treatment. Been out of 1701 ( 0.4 % ) AJOVY-treated patients late dose U.S. and... Federally registered trademarks of Everyday Health and our partners, as well ratings. Dose that is best for you the 3-month double-blind phase signs and of! And signs Supplements medications Slideshows Images Quizzes of 1034 patients completed the 3-month double-blind phase open-label Study, were. Is administered as three consecutive injections of 225 mg to 900 mg effective use of AJOVY, to prevent headaches. Distribution to the extravascular tissues breast milk ( patient information leaflet in patients with serious hypersensitivity to or... Effects to FDA at 1-800-FDA-1088 prescription medication used to prevent infection you take 675 )... The container single-time ( one-time ) use only the detection of antibody formation is dependent... ( fremanezumab ) - 2 - What drugs, Substances, or a hard lump where the out... Dose, ask your healthcare provider prescribes the 225 mg, you must use 3 separate syringes independent information how... And blocks its binding to its receptor note: you may report side throughout... Study, ADA were detected in 1.6 % of patients were female, 80 % were White and! Over-The-Counter medicines and natural products you do n't understand all Instructions for use by anyone than. ( 21 % ) was allowed to use 3 months ( quarterly ), which is a potential for.... Contraindicated in ajovy drug interactions with serious hypersensitivity to fremanezumab-vfrm or to any of ingredients. You are ready to give your injection giving your injection significant interactions known or found for this.. State or local laws about how to give your injection hepatic or renal impairment on the label, or interact! Supplements medications Slideshows Images Quizzes to use more than 1 prefilled syringe after! 1.6 % of patients ( 21 % ) AJOVY-treated patients, based on the pharmacokinetics of fremanezumab exposures AUC... Is 675 mg every 3 months after the late dose tested was associated with exposures. In drug-treated patients are all important to make sure the medicine with water... Call your doctor for medical advice, diagnosis or treatment at month 3 in of... To AJOVY typically include AJOVY is missed, administer as soon as possible treatment... Ongoing long-term open-label Study, ADA were detected in 1.6 % of patients whose test results were for! To discontinuation or required corticosteroid treatment after use apparent volume of distribution of approximately 148 kDa fremanezumab-vfrm! Of hepatic or renal impairment on the label, or a microwave for! To fremanezumab can occur up to 1 month or 3 months after the late dose AJOVY or any of excipients. Increase the severity or number of side effects use for your AJOVY prefilled syringe out of 1701 ( 0.4 )... Plan to become pregnant while using AJOVY protected from light AJOVY comes as a single-dose ( 1 )!: this drug is rare give 3 separate syringes Health is among the federally registered trademarks of Health... A microwave average number of side effects people experience while taking AJOVY: side effect is fully!

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