Brand Name

Relpax

Generic Name
Eletriptan
View Brand Information
FDA approval date: December 26, 2002
Classification: Serotonin-1b and Serotonin-1d Receptor Agonist
Form: Tablet

What is Relpax (Eletriptan)?

RELPAX is indicated for the acute treatment of migraine with or without aura in adults. RELPAX is a serotonin receptor agonist indicated for the acute treatment of migraine with or without aura in adults Limitations of Use: Use only after a clear diagnosis of migraine has been established , Not indicated for the prophylactic therapy of migraine , Not indicated for the treatment of cluster headache Limitations of Use:, Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with RELPAX, reconsider the diagnosis of migraine before RELPAX is administered to treat any subsequent attacks., RELPAX is not intended for the prevention of migraine attacks., Safety and effectiveness of RELPAX have not been established for cluster headache.

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Brand Information

Relpax (eletriptan hydrobromide)
1INDICATIONS AND USAGE
RELPAX is indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use:
  • Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with RELPAX, reconsider the diagnosis of migraine before RELPAX is administered to treat any subsequent attacks.
  • RELPAX is not intended for the prevention of migraine attacks.
  • Safety and effectiveness of RELPAX have not been established for cluster headache.
2DOSAGE AND ADMINISTRATION
The maximum recommended single dose is 40 mg.
In controlled clinical trials, single doses of 20 mg and 40 mg were effective for the acute treatment of migraine in adults. A greater proportion of patients had a response following a 40 mg dose than following a 20 mg dose
If the migraine has not resolved by 2 hours after taking RELPAX, or returns after transient improvement, a second dose may be administered at least 2 hours after the first dose. The maximum daily dose should not exceed 80 mg.
The safety of treating an average of more than 3 migraine attacks in a 30-day period has not been established.
3DOSAGE FORMS AND STRENGTHS
20 mg Tablets: Orange, round, convex shaped, film-coated, debossed with “REP 20” on one side and “VLE” on the other side.
40 mg Tablets: Orange, round, convex shaped, film-coated, debossed with “REP 40” on one side and “VLE” on the other side.
4CONTRAINDICATIONS
RELPAX is contraindicated in patients with:
  • Ischemic coronary artery disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary artery vasospasm, including Prinzmetal's angina
  • Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders
  • History of stroke, transient ischemic attack (TIA), or history or current evidence of hemiplegic or basilar migraine because these patients are at a higher risk of stroke
  • Peripheral vascular disease
  • Ischemic bowel disease
  • Uncontrolled hypertension
  • Recent use (i.e., within 24 hours) of another 5-hydroxytryptamine
  • Hypersensitivity to RELPAX (angioedema and anaphylaxis seen)
  • Recent use (i.e., within at least 72 hours) of the following potent CYP3A4 inhibitors: ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, or nelfinavir
5WARNINGS AND PRECAUTIONS
RELPAX should only be used where a clear diagnosis of migraine has been established.
5.1Myocardial Ischemia, Myocardial Infarction, and Prinzmetal's Angina
RELPAX is contraindicated in patients with ischemic or vasospastic CAD. There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of RELPAX. Some of these reactions occurred in patients without known CAD. RELPAX may cause coronary artery vasospasm (Prinzmetal's angina), even in patients without a history of CAD.
Perform a cardiovascular evaluation in triptan-naïve patients who have multiple cardiovascular risk factors (e.g., increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD) prior to receiving RELPAX. Do not use RELPAX if there is evidence of CAD or coronary artery vasospasm
5.2Arrhythmias
Life-threatening disturbances of cardiac rhythm including ventricular tachycardia and ventricular fibrillation leading to death have been reported within a few hours following the administration of 5-HT
5.3Chest, Throat, Neck and/or Jaw Pain/Tightness/Pressure
Sensations of tightness, pain, and pressure in the chest, throat, neck, and jaw commonly occur after treatment with RELPAX and are usually non-cardiac in origin. However, perform a cardiac evaluation if these patients are at high cardiac risk. RELPAX is contraindicated in patients with CAD or Prinzmetal's variant angina
5.4Cerebrovascular Events
Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT
Before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with symptoms atypical of migraine, other potentially serious neurological conditions need to be excluded. RELPAX is contraindicated in patients with a history of stroke or TIA
5.5Other Vasospasm Reactions
RELPAX may cause non-coronary vasospastic reactions, such as peripheral vascular ischemia, gastrointestinal vascular ischemia and infarction (presenting with abdominal pain and bloody diarrhea), and Raynaud's syndrome. In patients who experience symptoms or signs suggestive of a vasospastic reaction following the use of any 5-HT
5.6Medication Overuse Headache
Overuse of acute migraine drugs (e.g., ergotamine, triptans, opioids, or combination of these drugs for 10 or more days per month) may lead to exacerbation of headache (medication overuse headache). Medication overuse headache may present as migraine-like daily headaches or as a marked increase in frequency of migraine attacks. Detoxification of patients, including withdrawal of the overused acute migraine drugs and treatment of withdrawal symptoms (which often includes a transient worsening of headache) may be necessary.
5.7Serotonin Syndrome
Serotonin syndrome may occur with RELPAX, particularly during co-administration with selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and monoamine oxidase (MAO) inhibitors
5.8Increase in Blood Pressure
Significant elevation in blood pressure, including hypertensive crisis with acute impairment of organ systems, has been reported on rare occasions in patients treated with 5-HT
5.9Anaphylactic/Anaphylactoid Reactions
There have been reports of anaphylaxis, anaphylactoid, and hypersensitivity reactions including angioedema in patients receiving RELPAX. Such reactions can be life-threatening or fatal. In general, anaphylactic reactions to drugs are more likely to occur in individuals with a history of sensitivity to multiple allergens. RELPAX is contraindicated in patients with a history of hypersensitivity reaction to RELPAX
6ADVERSE REACTIONS
The following adverse reactions are described elsewhere in other sections of the prescribing information:
  • Myocardial ischemia and myocardial infarction, and Prinzmetal's angina
  • Arrhythmias
  • Chest, throat, neck, and/or jaw pain/tightness/pressure
  • Cerebrovascular events
  • Other vasospasm reactions
  • Medication overuse headache
  • Serotonin syndrome
  • Increase in blood pressure
  • Hypersensitivity reactions
6.1Clinical Trials Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Among 4,597 patients who treated the first migraine headache with RELPAX in short-term placebo-controlled trials, the most common adverse reactions reported with treatment with RELPAX were asthenia, nausea, dizziness, and somnolence. These reactions appear to be dose-related.
In long-term open-label studies where patients were allowed to treat multiple migraine attacks for up to 1 year, 128 (8.3%) out of 1,544 patients discontinued treatment due to adverse reactions.
Table 1 lists adverse reactions that occurred in the subset of 5,125 migraineurs who received eletriptan doses of 20 mg, 40 mg and 80 mg or placebo in worldwide placebo-controlled clinical trials.
Only adverse reactions that were more frequent in a RELPAX treatment group compared to the placebo group with an incidence greater than or equal to 2% are included in Table 1.
The frequency of adverse reactions in clinical trials did not increase when up to 2 doses of RELPAX were taken within 24 hours. The incidence of adverse reactions in controlled clinical trials was not affected by gender, age, or race of the patients. Adverse reaction frequencies were also unchanged by concomitant use of drugs commonly taken for migraine prophylaxis (e.g., SSRIs, beta blockers, calcium channel blockers, tricyclic antidepressants), estrogen replacement therapy or oral contraceptives.
6.2Postmarketing Experience
The following adverse reaction(s) have been identified during post approval use of RELPAX. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Neurological: seizure
Digestive: vomiting
7OVERDOSAGE
The elimination half-life of eletriptan is about 4 hours
There is no specific antidote to eletriptan.
It is unknown what effect hemodialysis or peritoneal dialysis has on the serum concentration of eletriptan.
8DESCRIPTION
RELPAX (eletriptan hydrobromide) tablets contain eletriptan hydrobromide, which is a selective 5-hydroxytryptamine 1B/1D (5-HT
Chemical Structure
The empirical formula is C
Each RELPAX Tablet for oral administration contains 24.2 or 48.5 mg of eletriptan hydrobromide equivalent to 20 mg or 40 mg of eletriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, FD&C Yellow No. 6 Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin USP.
9CLINICAL STUDIES
The efficacy of RELPAX in the acute treatment of migraines was evaluated in eight randomized, double-blind placebo-controlled studies. All eight studies used 40 mg. Seven studies evaluated an 80 mg dose and two studies included a 20 mg dose.
In all eight studies, randomized patients treated their headaches as outpatients. Seven studies enrolled adults and one study enrolled adolescents (ages 11 to 17). Patients treated in the seven adult studies were predominantly female (85%) and Caucasian (94%) with a mean age of 40 years (range 18 to 78). In all studies, patients were instructed to treat a moderate to severe headache. Headache response, defined as a reduction in headache severity from moderate or severe pain to mild or no pain, was assessed up to 2 hours after dosing. Associated symptoms such as nausea, vomiting, photophobia and phonophobia were also assessed.
Maintenance of response was assessed for up to 24 hours post dose. In the adult studies, a second dose of RELPAX or other medication was allowed 2 to 24 hours after the initial treatment for both persistent and recurrent headaches. The incidence and time to use of these additional treatments were also recorded.
In the seven adult studies, the percentage of patients achieving headache response 2 hours after treatment was significantly greater among patients receiving RELPAX at all doses compared to those who received placebo. The 2-hour response rates from these controlled clinical studies are summarized in Table 2.
Comparisons of the performance of different drugs based upon results obtained in different clinical trials are never reliable. Because studies are generally conducted at different times, with different samples of patients, by different investigators, employing different criteria and/or different interpretations of the same criteria, under different conditions (dose, dosing regimen, etc.), quantitative estimates of treatment response and the timing of response may be expected to vary considerably from study to study.
The estimated probability of achieving an initial headache response within 2 hours following treatment is depicted in Figure 1.
Figure 1
*Figure 1 shows the Kaplan-Meier plot of probability over time of obtaining headache response (no or mild pain) following treatment with eletriptan. The plot is based on 7 placebo-controlled, outpatient trials in adults providing evidence of efficacy (Studies 1 through 7). Patients not achieving headache response or taking additional treatment prior to 2 hours were censored at 2 hours.
For patients with migraine-associated photophobia, phonophobia, and nausea at baseline, there was a decreased incidence of these symptoms following administration of RELPAX as compared to placebo.
Two to 24 hours following the initial dose of study treatment, patients were allowed to use additional treatment for pain relief in the form of a second dose of study treatment or other medication. The estimated probability of taking a second dose or other medications for migraine over the 24 hours following the initial dose of study treatment is summarized in Figure 2.
Figure 2
*This Kaplan-Meier plot is based on data obtained in 7 placebo-controlled trials in adults (Studies 1 through 7). Patients were instructed to take a second dose of study medication as follows: a) in the event of no response at 2 hours (studies 2 and 4-7) or at 4 hours (study 3); b) in the event of headache recurrence within 24 hours (studies 2-7). Patients not using additional treatments were censored at 24 hours. The plot includes both patients who had headache response at 2 hours and those who had no response to the initial dose. It should be noted that the protocols did not allow re-medication within 2 hours post dose.
The efficacy of RELPAX was unaffected by the duration of attack, gender or age of the patient, relationship to menses, or concomitant use of estrogen replacement therapy/oral contraceptives or frequently used migraine prophylactic drugs.
In a single study in adolescents (n=274), there were no statistically significant differences between treatment groups. The headache response rate at 2 hours was 57% for both RELPAX 40 mg Tablets and placebo.
10HOW SUPPLIED/STORAGE AND HANDLING
RELPAX Tablets containing 20 mg or 40 mg eletriptan (base) as the hydrobromide salt. RELPAX Tablets are orange, round, convex shaped, film-coated tablets with appropriate debossing.
They are supplied in the following strengths and package configurations:
RELPAX Tablets
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
11PATIENT COUNSELING INFORMATION
See
Myocardial Ischemia and/or Infarction, Prinzmetal’s Angina, Other Vasospastic Reactions, and Cerebrovascular Events
Inform patients that RELPAX may cause serious cardiovascular adverse reactions such as myocardial infarction or stroke, which may result in hospitalization and even death. Although serious cardiovascular reactions can occur without warning symptoms, instruct patients to be alert for the signs and symptoms of chest pain, shortness of breath, weakness, slurring of speech, and instruct them to ask for medical advice when observing any indicative sign or symptoms. Instruct patients to seek medical advice if they have symptoms of other vasospastic reactions
Anaphylactic/Anaphylactoid Reactions
Inform patients that anaphylactic/anaphylactoid reactions have occurred in patients receiving RELPAX. Such reactions can be life-threatening or fatal. In general, anaphylactic reactions to drugs are more likely to occur in individuals with a history of sensitivity to multiple allergens
Medication Overuse Headache
Inform patients that use of drugs to treat acute migraines for 10 or more days per month may lead to an exacerbation of headache, and encourage patients to record headache frequency and drug use (e.g., by keeping a headache diary)
Serotonin Syndrome
Inform patients about the risk of serotonin syndrome with the use of RELPAX or other triptans, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs)
Pregnancy
Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during therapy
Lactation
Inform patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed
Distributed by:
© 2024 Viatris Inc.
RELPAX is a registered trademark of Viatris Specialty LLC, a Viatris Company.
UPJ:RLPX:R2
12Patient Information
RELPAX
(eletriptan hydrobromide)
Tablets
Please read this information before you start taking RELPAX and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.
What is the most important information I should know about RELPAX?
RELPAX can cause serious side effects, including:
Heart attack and other heart problems. Heart problems may lead to death.
Stop taking RELPAX and get emergency medical help right away if you have any of the following symptoms of a heart attack:
  • discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
  • chest pain or chest discomfort that feels like an uncomfortable heavy pressure, squeezing, fullness, or pain
  • pain or discomfort in your arms, back, neck, jaw, or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded
RELPAX is not for people with risk factors for heart disease unless a heart exam is done and shows no problem. You have a higher risk for heart disease if you:
  • have high blood pressure
  • have high cholesterol levels
  • smoke
  • are overweight
  • have diabetes
  • have a family history of heart disease
  • are a female who has gone through menopause
  • are a male over age 40
Serotonin syndrome. Serotonin syndrome is a serious and life-threatening problem that can happen in people taking RELPAX, especially if RELPAX is taken with anti-depressant medicines called selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs).
Ask your doctor or pharmacist for a list of these medicines if you are not sure.
Call your doctor right away if you have any of the following symptoms of serotonin syndrome:
  • mental changes such as seeing things that are not there (hallucinations), agitation, or coma
  • fast heartbeat
  • changes in blood pressure
  • high body temperature
  • tight muscles
  • trouble walking
  • nausea, vomiting, or diarrhea
What is RELPAX?
RELPAX is a prescription medicine used to treat acute migraine headaches with or without aura in adults.
RELPAX is for people who have been diagnosed with migraine headaches.
RELPAX is not used to prevent or decrease the number of migraine headaches you have.
It is not known if RELPAX is safe and effective to treat cluster headaches.
It is not known if RELPAX is safe and effective in children.
Who should not take RELPAX?
Do
  • have heart problems or a history of heart problems
  • have or have had a stroke or problems with your blood circulation
  • have hemiplegic or basilar migraines. If you are not sure if you have these types of migraines, ask your doctor.
  • have narrowing of the blood vessels in your legs, arms, stomach, or kidney (peripheral vascular disease)
  • have ischemic bowel disease
  • have uncontrolled high blood pressure
  • have taken any of the following medicines in the last 24 hours:
  • ergotamines such as:
  • dihydroergotamines such as:
  • have taken the following medicines within the last 72 hours:
  • are allergic to eletriptan or any of the ingredients in RELPAX. See the end of this leaflet for a complete list of ingredients in RELPAX.
What should I tell my doctor before taking RELPAX?
Before you take RELPAX, tell your doctor if you:
  • have heart problems or family history of heart problems or stroke
  • have high blood pressure
  • have high cholesterol
  • have diabetes
  • smoke
  • are overweight
  • are a female who has gone through menopause
  • have kidney problems
  • have liver problems
  • are pregnant or plan to become pregnant. It is not known if RELPAX will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. RELPAX passes into your breast milk and may harm your baby. Talk to your doctor about the best way to feed your baby if you take RELPAX.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Your doctor will decide if you can take RELPAX with your other medicines. RELPAX and other medicines may affect each other causing side effects.
Especially tell your doctor if you take anti-depressant medicines called:
  • selective serotonin reuptake inhibitors (SSRIs)
  • serotonin and norepinephrine reuptake inhibitors (SNRIs)
Ask your doctor or pharmacist for a list of these medicines if you are not sure.
Know the medicines you take. Keep a list of them to show your doctor or pharmacist when you get a new medicine.
How should I take RELPAX?
  • Take RELPAX exactly as your doctor tells you to take it.
  • Your doctor will tell you how much RELPAX to take and when to take it.
  • Your doctor may change your dose if needed. Do not change your dose without first talking to your doctor.
  • Take 1 RELPAX tablet as soon as you feel a migraine coming on.
  • If you do not get any relief after your first RELPAX tablet, do not take a second tablet without first talking with your doctor.
  • If your headache comes back or you only get some relief from your headache, you can take a second tablet 2 hours after the first tablet.
  • Do not take more than a total of 80 mg of RELPAX tablets in a 24-hour period.
  • If you take too much RELPAX, call your doctor or go to the nearest hospital emergency room right away.
  • You should write down when you have headaches and when you take RELPAX so you can talk to your doctor about how well RELPAX is working for you.
What should I avoid while taking RELPAX?
RELPAX can cause dizziness, weakness, or drowsiness. If you have these symptoms, do not drive a car, use machinery, or do anything where you need to be alert.
What are the possible side effects of RELPAX?
RELPAX may cause serious side effects. See "What is the most important information I should know about RELPAX?"
These serious side effects include:
  • changes in color or sensation in your fingers and toes (Raynaud's syndrome)
  • stomach and intestinal problems (gastrointestinal and colonic ischemic events). Symptoms of gastrointestinal and colonic ischemic events include:
  • sudden or severe stomach pain
  • stomach pain after meals
  • weight loss
  • nausea or vomiting
  • constipation or diarrhea
  • bloody diarrhea
  • fever
  • problems with blood circulation to your legs and feet (peripheral vascular ischemia). Symptoms of peripheral vascular ischemia include:
  • cramping and pain in your legs or hips
  • feeling of heaviness or tightness in your leg muscles
  • burning or aching pain in your feet or toes while resting
  • numbness, tingling, or weakness in your legs
  • cold feeling or color changes in 1 or both legs or feet
  • medication overuse headaches. Some people who take too many RELPAX may have worse headaches (medication overuse headache). If your headaches get worse, your doctor may decide to stop your treatment with RELPAX.
The most common side effects of RELPAX include:
  • dizziness
  • nausea
  • weakness
  • tiredness
  • drowsiness
Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of RELPAX. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
How should I store RELPAX?
• Store RELPAX at room temperature between 68°F to 77°F (20°C to 25°C).
General information about the safe and effective use of RELPAX
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use RELPAX for a condition for which it was not prescribed. Do not give RELPAX to other people, even if they have the same symptoms you have. It may harm them.
This Patient Information summarizes the most important information about RELPAX. If you would like more information about RELPAX, talk with your doctor. You can ask your doctor or pharmacist for information on RELPAX that is written for health professionals.
For more information, call Viatris at 1-877-446-3679 (1-877-4-INFO-RX).
What are the ingredients in RELPAX?
Active ingredient: eletriptan hydrobromide
Inactive ingredients: croscarmellose sodium, FD&C Yellow No. 6 Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin.
Distributed by:
© 2024 Viatris Inc.
RELPAX is a registered trademark of Viatris Specialty LLC, a Viatris Company.
The brands listed are trademarks of their respective owners.
This Patient Information has been approved by the U.S. Food and Drug Administration.
UPJ:PL:RLPX:R2
Revised: 1/2024
13PRINCIPAL DISPLAY PANEL - 20 mg
20mg*
NDC 58151-367-56
RELPAX
(eletriptan HBr)
6 tablets
Store at 20°C to 25°C (68°F to 77°F);
DOSAGE AND USE
*Each tablet contains eletriptan hydrobromide
MADE IN ITALY
Distributed by:
Viatris Specialty LLCMorgantown, WV 26505 U.S.A.
© 2023 Viatris Inc.
RELPAX is a registered trademark
UPJ:367:6C:R1
Relpax (eletriptan HBr) 20 mg Carton Label
14PRINCIPAL DISPLAY PANEL - 40 mg
40mg*
NDC 58151-368-56
RELPAX
(eletriptan HBr)
6 tablets
Store at 20°C to 25°C (68°F to 77°F);
DOSAGE AND USE
See accompanying prescribing information.
*Each tablet contains eletriptan hydrobromide
MADE IN ITALY
Distributed by:
Viatris Specialty LLCMorgantown, WV 26505 U.S.A.
© 2023 Viatris Inc.
RELPAX is a registered trademark
UPJ:368:6C:R1
Relpax (eletriptan HBr) 40 mg Carton Label