Incidence And Characterization Of Treatment
The incidence and severity of alopecia during the double-blind treatment phase ofEVOLVE-1, EVOLVE-2, and REGAIN for migraine prevention are summarized in Incidence and Severity of Treatment-Emergent Alopecia Events in EVOLVE-1, EVOLVE-2, and REGAIN Studies: Double-Blind Treatment Phase.
The alopecia events were mild or moderate in severity, with no severe events reported. One placebo-treated patient from the REGAIN study discontinued due to treatment-emergent alopecia.5
|
TEAE |
Abbreviations: GMB = galcanezumab PBO = placebo TEAE = treatment-emergent adverse event.
No patients in the CONQUER study experienced treatment-emergent alopecia during double-blind treatment.5
What Patients Are Saying
Members of the Migraine community are talking, and were listening. Heres just a bit of the buzz around Ubrelvy and other gepants:
I had a heart attack so my triptan use is very, very limited. I cut mine in half and take when desperate, but sometimes I get chest pain from it so I hate them. -Sherrie
I havent been pain-free in 20 years. I so want to try these new meds! Diana
Will be interesting to see if the side effects are better than triptans like Imitrex & if these can be taken more than 9x/mo! Imitrex works well for me 75% of the time, but the side effects are usually extremely limiting. My body feels bruised & heavy, Im extremely fatigued & need extra sleep, my hair & tongue hurt, etc. -Anonymous
A New Class Of Drugs For Migraine Prevention
In 2018, FDA approved 3 new biological products for migraines based on evidence they could reduce the number of headache days per month in many patients. The drugs were:
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Erenumab-aooe , approved in May 2018, with 277,400 outpatient prescriptions in Quarter 1, 2019
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Fremanezumab-vfrm , approved in September 2018, with 79,700 prescriptions in Quarter 1, 2019
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Galcanezumab-gnlm , approved in September 2018, with 65,300 prescriptions in Quarter 1, 2019
All three drugs are genetically engineered monoclonal antibodies that target a highly prevalent signaling molecule, calcitonin gene-related peptide . While CGRP has many functions vascularly, it has been linked to some migraine headaches. These drugs are given subcutaneously once a month .
Premarket studies. All three drugs reduced the number of migraine headache days by a median of 1 to 2 days per month compared to placebo in a group of episodic migraine patients who had been experiencing 8 to 9 headache days per month. Large variability in effects was a striking feature. Outcomes ranged from no effect in 15% of patients, to 20% who reported that treatment eliminatedor nearly eliminatedmigraine headaches that had afflicted them for many years. Also, trials showed a substantial placebo effect.
Although the CGRP molecular target has other roles in the body , erenumab-aooe clinical trials revealed only a few adverse events occurring 2% more frequently than placebo: constipation, cramps/muscle spasms, and injection site reactions.
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Does Emgality Cause Side Effects
Emgality is a humanized IgG4 monoclonal antibody specific for calcitonin-gene related peptide ligand used for the preventive treatment of migraine in adults.
Common side effects of Emgality include injection site reactions such as pain, redness, and itching.
Serious side effects of Emgality include allergic reactions such as itching, rash, hives, trouble breathing, and swelling of the face, mouth, tongue, or throat
There are no listed drug interactions of Emgality. There are no adequate data on the developmental risk associated with the use of Emgality in pregnant women. There are no data on the presence of Emgality in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mothers clinical need for Emgality and any potential adverse effects on the breastfed infant from Emgality or from the underlying maternal condition.
Let Aimovig Warm To Room Temperature Before An Injection
To avoid injection site reactions, dont be hasty when giving an injection. Injecting cold medicine can cause pain and redness. Remove the Aimovig autoinjector or prefilled syringe from the refrigerator about 30 minutes before an injection. Let it stand in the carton protected from light to warm up to room temperature. Dont heat it in any way, just let the ambient room temperature warm it up. After 30 minutes, the medicine should be ready for injection.
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Additional Published Information On Alopecia
Alopecia is more common in women than men, and its prevalence increases with age.12 In the United Kingdom and United States, the prevalence of alopecia is
- 3% to 6% in women < 30 years of age, and
- 29% to 42% in women 70 years of age.12-14
The prevalence of alopecia also increases with age in men, affecting more than 80% of Caucasian men 70 years of age.12,15-18
The hair follicle is a unique organ in the body that undergoes cycles of
- hair production
Should I Expect To Have Fatigue When Using Aimovig
No. A lack of energy known as fatigue isnt a side effect of Aimovig. Fatigue wasnt reported in clinical studies of the medication.
But it is common to feel fatigue before, during, or after a migraine.
If youre concerned about fatigue while using Aimovig, talk with your doctor or pharmacist. They may be able to suggest ways to help boost your energy.
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How Should I Use Emgality
Use Emgality exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.
Emgality is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself.
For prevention of migraine headaches: Emgality is usually given as a first dose of 2 injections, followed by 1 injection once per month.
For treatment of a cluster headache episodes: Emgality is usually given as 3 injections at the start of the cluster period, followed by 1 injection once per month until the end of the cluster period.
Follow your doctor’s dosing instructions very carefully.
Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don’t understand all instructions.
Prepare an injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.
Avoid injecting into skin that is hard, red, bruised, or tender.
Store this medicine in its original carton in the refrigerator, protected from light. Do not freeze or shake the medicine.
You may briefly store Emgality at room temperature. Protect from light and use the medicine within 7 days. Do not put it back in the refrigerator.
Each prefilled syringe or injection pen is for one use only. Throw it away after one use, even if there is still medicine left inside.
Alcohol Use And Emgality
It should be safe to drink alcohol while using Emgality. However, alcohol may trigger migraine attacks or cluster headache symptoms.
Also, alcohol can harm your liver, and certain headache pain relievers that contain acetaminophen can cause this damage, too. Drinking alcohol with these pain relievers can raise your risk for liver problems. So, you should avoid alcohol if you use acetaminophen products.
If you drink alcohol, ask your doctor how much is safe for you to drink with your condition and treatment plan.
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Aimovig Side Effects And How To Avoid Them
Aimovig side effects | Serious side effects | High blood pressure | Hair loss | Immunogenicity | How long do side effects last? | Warnings | Interactions | How to avoid side effects | Resources
Aimovig is a brand-name prescription drug taken as a once-monthly injection to prevent episodic or chronic migraine headaches. The active ingredient in Aimovig is erenumab-aooe, a monoclonal antibody that blocks the CGRP receptor to prevent inflammation associated with migraines. Although effective at reducing the number of migraine days each month, Aimovig may cause certain side effects, which may be worsened by pre-existing conditions or drug interactions.
Can I Take This If I Have A Heart Condition Or If I Have A High Risk Of A Cardiovascular Event
UBRELVY is not contraindicated with cardiovascular conditions. There currently are no cardiovascular warnings and precautions
Unlike triptans, the class of medications called the gepants does not act as a vasodilator. That means it should be safe for those with heart problems or at a high risk for cardiovascular events. Talk to your doctor.
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What To Ask Your Doctor
Emgality may give you more migraine-free days or help relieve your cluster headache symptoms. But while using Emgality, some people may experience mild reactions at the injection site . And in rare cases, Emgality may cause a serious or life threatening allergic reaction.
If you have questions about Emgalitys side effects, talk with your doctor or pharmacist. They can help answer questions such as:
- What are some tips to help prevent injection-site reactions when using Emgality?
- If I have a mild allergic reaction that goes away, can I keep using Emgality?
- How can I tell the difference between an injection-site reaction and an allergic reaction?
- What can I do to manage injection-site reactions?
If you use Emgality for migraine, subscribe to our migraine newsletter for trusted remedies, coping techniques, and expert advice.
Are Two Days A Month Of Relief Worth It
A small number of clinical trials have been conducted comparing erenumab to placebo. In the Sun et al. phase II trial , participants who received the monthly erenumab injections at a very low dose had, on average, 1.1 fewer days of migraines per month than the participants who got a placebo. A phase III trial compared placebo to the now-standard dose and to a double dose, and they observed a reduction of 1.4 fewer days for 70 mg and 1.9 fewer days for 140 mg compared to placebo. This was in a population of patients who had, on average, 8.3 days of migraines each month.
The most recent human study to be published, also funded by Amgen, is the ARISE trial, which reported 1 fewer day of migraines a month when compared to placebo.
The drug was also tested in patients with chronic migraines, meaning people who experience at least 15 headache days per month. The result of this Amgen-funded trial? A reduction of 2.5 days per month for the erenumab group compared to placebo.
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Dr Robbins & Cgrp Part I
We were privileged to have Dr. Lawrence Robbins doing a Facebook Live Chat in our group on May 21, 2019. Dr Robbins talked about the CGRP Medications one year after the first medication was FDA approved, and answered questions about how the efficacy and side effects seen in the pharmaceutical trials are holding up in widespread clinical practice. This document is a transcript of the questions and answers from that event, and the complete video can be viewed here: .
The CGRP and Migraine Community group welcomes anyone who lives with migraine as well as their caregivers. The group exists to support, guide and educate the migraine community through the emergence and use of this new class of migraine medications, CGRP inhibitors. You can find the group at: .
Before Taking This Medicine
You should not use Emgality if you are allergic to galcanezumab.
Emgality is not approved for use by anyone younger than 18 years old.
Tell your doctor if you are pregnant. It is not known whether galcanezumab will harm an unborn baby. However, having migraine headaches during pregnancy may cause preeclampsia . The benefit of preventing migraines may outweigh any risks to the baby.
It may not be safe to breast-feed while using galcanezumab. Ask your doctor about any risk.
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Tell The Healthcare Provider About All Medications Being Taken
Aimovig has few drug interactions. The FDA lists no significant drug interactions in Aimovigs official drug information. Even so, it is important to tell the prescribing healthcare provider about all medications and supplements being taken. To prevent severe constipation when taking Aimovig, the healthcare provider may need to know if you take certain drugs that slow down movement in the intestines, such as antidiarrheals or opioids.
Emgality For Migraine Prevention
Emgality is FDA-approved to prevent migraine headaches in adults. Its used to prevent both episodic and chronic migraine headaches. Chronic migraine headaches occur on 15 or more days per month, while episodic migraine headaches occur on fewer than 15 days per month.
Effectiveness for migraine prevention
In a clinical study of people with chronic migraine, people taking Emgality lowered their number of monthly headache days by 4.8 days. In comparison, people taking a placebo lowered their number of monthly headache days by 2.7 days.
Also, 28% of people who took Emgality for 3 months had their number of migraine days per month cut in half. In comparison, 15% of people taking a placebo had their number of migraine days per month cut in half.
In clinical studies of people with episodic migraine, people taking Emgality lowered the number of monthly headache days by about 4.5 days. In comparison, people taking placebo lowered the number of monthly headache days by about 2.5 days.
Also, around 60% of people taking Emgality cut their number of migraine days at least in half over 6 months. In comparison, nearly 40% of people taking placebo cut their number of migraine days in at least half over 6 months. Up to 16% of people taking Emgality were migraine-free over 6 months of treatment compared to 6% in people taking placebo.
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Alcohol Use With Ajovy
Alcohol isnt known to affect Ajovy. However, alcohol can be a trigger for migraine in some people.
If youre not sure what triggers your migraine episodes, its useful to keep a migraine diary. This can help you determine if your migraines are linked to certain drinks, foods, or situations. If you notice that alcohol triggers your migraine episodes or makes them worse, it may help to avoid drinking alcohol. You can talk with your doctor to learn more.
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Does Aimovig Cause Memory Problems Diarrhea Insomnia Or Muscle Pain
No. Aimovig isnt known to cause memory problems, diarrhea, insomnia , or muscle pain. These side effects werent reported in studies of the drug.
However, diarrhea and insomnia are possible symptoms of a migraine headache, which Aimovig helps prevent. So you may have diarrhea and insomnia while taking Aimovig. But its possible that these symptoms may be caused by migraine, not by Aimovig.
If you have any of the side effects above while taking Aimovig, talk with your doctor. They can suggest ways to ease your symptoms.
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Evidence From Clinical Studies
Even though the knowledge of the presence and function of CGRP in the CNS is sparse, the function in both the peripheral and enteric nervous system is well established and CGRP is expressed widely throughout both systems. Thus, a wide variety of possible adverse events could be anticipated when blocking CGRP. However, reported adverse events after blocking of CGRP have in general been mild to moderate and the incidences have been low.
Among the first CGRP receptor antagonists under trial, intravenous olcegepant caused mild to moderate adverse events such as paresthesia, nausea, headache, dry mouth and unspecific vision disturbances in a minority of patients . However, more serious adverse events were reported with telcagepant and MK-3207, which caused liver toxicity with transient increase of transaminases in a small group of included subjects upon repeated doses. This lead to discontinuation of the trial program for these molecules . Other non-peptide CGRP receptor antagonists such as BI44370TA, BMS-927711, and, most recently, MK-1602 have also been tested. For all three molecules adverse events were mild to moderate and the incidence was low and similar to the placebo group . No liver toxicity was reported for these drugs, and the gepant program is thus still ongoing.
Cgrp Monoclonal Antibodies For Chronic Migraine: Year 1 Of Clinical Use
In the March 2019 issue of Practical Pain Management, the author shared his retrospective clinical and anecdotal experience with the new class of calcitonin gene-related peptide inhibitors, specifically, Aimovig as a preventive for chronic migraine. That report included data over a period of six months at the authors headache clinic in Illinois. In this follow-up report, the author recaps six months of Aimovig use as well as three months of use with two other CGRP-inhibiting products, both approved in September 2018: Emgality and Ajovy , including results seen when switching among the three available products.
Calcitonin gene-related peptide monoclonal antibodies are the first pharmacological treatments developed explicitly for the prevention of migraine.1-3 There are currently three antibodies available, Aimovig, Emgality, and Ajovy, all administered as a subcutaneous injection. A fourth compound was under development by Alder BioPharmaceuticals and update approved by FDA in February 2020 under Lunebeck which acquired Alder). This paper summarizes use of the first three available medications in an outpatient headache clinic over approximately one year, based on when each mAb entered the market. All patients had a diagnosis of chronic migraine. Many of these patients were refractory to standard preventive therapies. In addition, potential challenges surrounding long-term use of these important migraine preventives are discussed.
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