Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 01 March 2017

Indication(s)

1 INDICATIONS AND USAGE Sumavel DosePro is indicated in adults for (1) the acute treatment of migraine, with or without aura, and (2) the acute treatment of cluster headache. Limitations of Use: Use only if a clear diagnosis of migraine or cluster headache has been established. If a patient has no response to the first migraine attack treated with Sumavel DosePro, reconsider the diagnosis of migraine before Sumavel DosePro is administered to treat any subsequent attacks. Sumavel DosePro is not indicated for the prevention of migraine attacks. Sumavel® DosePro® is a serotonin (5-HT1B/1D) receptor agonist (triptan) indicated for: Acute treatment of migraine with or without aura in adults (1) Acute treatment of cluster headache in adults (1) Limitations of Use: Use only if a clear diagnosis of migraine or cluster headache has been established. (1) Not indicated for the prevention of migraine attacks. (1)

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Advisory information

contraindications
4 CONTRAINDICATIONS Sumavel DosePro 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 [see Warnings and Precautions ( 5.1 ) ] Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see Warnings and Precautions ( 5.2 ) ] History of stroke or transient ischemic attack (TIA) because these patients are at a higher risk of stroke [see Warnings and Precautions ( 5.4 ) ] History of hemiplegic or basilar migraine Peripheral vascular disease [see Warnings and Precautions ( 5.5 ) ] Ischemic bowel disease [see Warnings and Precautions ( 5.5 )] Uncontrolled hypertension [see Warnings and Precautions ( 5.8 ) ] Recent (i.e., within 24 hours) use of ergotamine-containing medication, ergot-type medication (such as dihydroergotamine or methysergide), or another 5-hydroxytryptamine1 (5-HT1) agonist [see Drug Interactions ( 7.1 , 7.3 )] Concurrent administration of a monamine oxidase (MAO)-A inhibitor or recent (within 2 weeks) use of an MAO-A inhibitor [see Drug Interactions ( 7.2 ) and Clinical Pharmacology ( 12.3 ) ] Hypersensitivity to Sumavel DosePro (angioedema and anaphylaxis seen) [see Warnings and Precautions ( 5.9 ) and Adverse Reactions ( 6 ) ] History of coronary artery disease or coronary vasospasm (4) Wolff-Parkinson-White syndrome or other cardiac accessory conduction pathway disorders (4) History of stroke, transient ischemic attack, or hemiplegic or basilar migraine (4) Peripheral vascular disease (4) Ischemic bowel disease (4) Uncontrolled hypertension (4) Recent (within 24 hours) use of another 5-HT1 agonist (e.g., another triptan) or of an ergotamine-containing medication (4) Current or recent (past 2 weeks) use of monoamine oxidase-A inhibitor (4) Hypersensitivity to Sumavel DosePro (angioedema and anaphylaxis seen) (4)
Adverse reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: Myocardial ischemia, myocardial infarction, and Prinzmetal’s angina [see Warnings and Precautions ( 5.1 ) ] Arrhythmias [see Warnings and Precautions ( 5.2 ) ] Chest, throat, neck, and/or jaw pain/tightness/pressure [see Warnings and Precautions ( 5.3 ) ] Cerebrovascular events [see Warnings and Precautions ( 5.4 ) ] Other vasospasm reactions [see Warnings and Precautions ( 5.5 ) ] Medication overuse headache [see Warnings and Precautions ( 5.6 ) ] Serotonin syndrome [see Warnings and Precautions ( 5.7 ) ] Increase in blood pressure [see Warnings and Precautions ( 5.8 ) ] Hypersensitivity reactions [see Contraindications ( 4 ) and Warnings and Precautions ( 5.9 ) ] Seizures [see Warnings and Precautions ( 5.10 ) ] Most common adverse reactions (≥5% and > placebo) were injection site reactions, tingling, dizziness/vertigo, warm/hot sensation, burning sensation, feeling of heaviness, pressure sensation, flushing, feeling of tightness, and numbness. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Endo Pharmaceuticals at 1-800-462-3636 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Migraine Headache: Table 1 lists adverse reactions that occurred in 2 US placebo-controlled clinical trials in migraine subjects [see Clinical Studies ( 14.1 ) ] following either a single 6 mg dose of sumatriptan injection or placebo. Only reactions that occurred at a frequency of 2% or more in groups treated with sumatriptan injection 6 mg and that occurred at a frequency greater than the placebo group are included in Table 1. Table 1. Adverse Reactions Reported by at Least 2% of Subjects and at a Greater Frequency Than Placebo in 2 Placebo-Controlled Migraine Clinical Trialsa Percent of Subjects Reporting Adverse Reaction Sumatriptan Injection 6 mg Subcutaneous (n = 547) Placebo (n = 370) Atypical sensations Tingling Warm/hot sensation Burning sensation Feeling of heaviness Pressure sensation Feeling of tightness Numbness Feeling strange Tight feeling in head 42 14 11 7 7 7 5 5 2 2 9 3 4 <1 1 2 <1 2 <1 <1 Cardiovascular Flushing 7 2 Chest discomfort Tightness in chest Discomfort: nasal cavity/sinuses 5 3 2 1 <1 <1 Injection site reactionb 59 24 Miscellaneous Jaw discomfort 2 0 Musculoskeletal Weakness Neck pain/stiffness Myalgia 5 5 2 <1 <1 <1 Neurological Dizziness/vertigo Drowsiness/sedation Headache 12 3 2 4 2 <1 Skin Sweating 2 1 a The sum of percentages cited is greater than 100% because subjects may have experienced more than 1 type of adverse reaction. Only reactions that occurred at a frequency of 2% or more in groups treated with sumatriptan injection and occurred at a frequency greater than that of the placebo group are included. b Includes injection site pain, stinging/burning, swelling, erythema, bruising, bleeding. The incidence of adverse reactions in controlled clinical trials was not affected by gender or age of the subjects. There were insufficient data to assess the impact of race on the incidence of adverse reactions. Cluster Headache: In the controlled clinical trials assessing the efficacy of sumatriptan injection as a treatment for cluster headache [see Clinical Studies ( 14.2 ) ], no new significant adverse reactions were detected that had not already been identified in trials of sumatriptan in subjects with migraine. Overall, the frequency of adverse reactions reported in the trials of cluster headache was generally lower than in the migraine trials. Exceptions include reports of paresthesia (5% sumatriptan, 0% placebo), nausea and vomiting (4% sumatriptan, 0% placebo), and bronchospasm (1% sumatriptan, 0% placebo).

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION For subcutaneous use only. (2.1, 2.2) Acute treatment of migraine: 4 mg or 6 mg single dose. (2.1) Acute treatment of cluster headache: 6 mg single dose. (2.1) Maximum dose in a 24-hour period: 12 mg. Separate doses by at least 1 hour. (2.1) Administer dose only to the abdomen or thigh. (2.2) DO NOT USE SUMAVEL DOSEPRO IF THE TIP OF THE DEVICE IS TITLED OR BROKEN OFF UPON REMOVAL FROM PACKAGING. ( 2.2 ) 2.1 Dosing Information The maximum single recommended dose of Sumavel DosePro for the acute treatment of migraine or cluster headache is 6 mg given subcutaneously. For the treatment of migraine, if side effects are dose limiting, a lower dose (4 mg) may be used [see Clinical Studies ( 14.1 ) ]. For the treatment of cluster headache, the efficacy of a lower dose has not been established. The maximum cumulative injected dose that may be given in 24 hours is 12 mg, with doses of Sumavel DosePro separated by at least 1 hour. Sumavel DosePro may be given at least 1 hour following a dose of another sumatriptan product. A second dose should only be considered if some response to a first dose was observed. 2.2 Administration Using Sumavel ® DosePro ® Sumavel DosePro is available for use as 4 mg or 6 mg needle-free delivery systems. It is intended to be given subcutaneously only. Sumavel DosePro is designed for patient self-administration to sites on the abdomen or the thigh with an adequate subcutaneous thickness to accommodate penetration of sumatriptan injection into the subcutaneous space. Administration should not be made within 2 inches of the naval. Sumavel DosePro is not to be administered to other areas of the body, including the arm. Instruct patients on the proper use of Sumavel DosePro and direct them to use proper injection sites. Instruct patients to not use Sumavel DosePro if the tip of the device is tilted or broken off upon removal from packaging [see Patient counseling Information (17) and Instructions for Use]. Sumavel DosePro is for single use only. Discard after use.
Use in special populations
8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm. (8.1) 8.1 Pregnancy Pregnancy Category C: There are no adequate and well-controlled trials of sumatriptan injection in pregnant women. Sumavel DosePro should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. When sumatriptan was administered intravenously to pregnant rabbits daily throughout the period of organogenesis, embryolethality was observed at doses at or close to those producing maternal toxicity. These doses were less than the maximum recommended human dose (MRHD) of 12 mg/day on a mg/m2 basis. Oral administration of sumatriptan to rabbits during organogenesis was associated with increased incidences of fetal vascular and skeletal abnormalities. The highest no-effect dose for these effects was 15 mg/kg/day. The intravenous administration of sumatriptan to pregnant rats throughout organogenesis at doses that are approximately 10 times the MRHD on a mg/m2 basis, did not produce evidence of embryolethality. The subcutaneous administration to pregnant rats prior to and throughout pregnancy did not produce evidence of embryolethality or teratogenicity. 8.3 Nursing Mothers It is not known whether sumatriptan is excreted in human breast milk following subcutaneous administration. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from Sumavel DosePro, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. 8.4 Pediatric Use Safety and effectiveness of sumatriptan injection in pediatric patients under 18 years of age have not been established; therefore, sumatriptan injection is not recommended for use in patients under 18 years of age. Two controlled clinical trials evaluated sumatriptan nasal spray (5 to 20 mg) in 1,248 adolescent migraineurs aged 12 to 17 years who treated a single attack. The trials did not establish the efficacy of sumatriptan nasal spray compared with placebo in the treatment of migraine in adolescents. Adverse reactions observed in these clinical trials were similar in nature to those reported in clinical trials in adults. Five controlled clinical trials (2 single-attack trials, 3 multiple-attack trials) evaluating oral sumatriptan (25 to 100 mg) in pediatric subjects aged 12 to 17 years enrolled a total of 701 adolescent migraineurs. These trials did not establish the efficacy of oral sumatriptan compared with placebo in the treatment of migraine in adolescents. Adverse reactions observed in these clinical trials were similar in nature to those reported in clinical trials in adults. The frequency of all adverse reactions in these subjects appeared to be both dose- and age-dependent, with younger subjects reporting reactions more commonly than older adolescents. Postmarketing experience documents that serious adverse reactions have occurred in the pediatric population after use of subcutaneous, oral, and/or intranasal sumatriptan. These reports include reactions similar in nature to those reported rarely in adults, including stroke, visual loss, and death. A myocardial infarction has been reported in a 14-year-old male following the use of oral sumatriptan; clinical signs occurred within 1 day of drug administration. Since clinical data to determine the frequency of serious adverse reactions in pediatric patients who might receive subcutaneous, oral, or intranasal sumatriptan are not presently available, the use of sumatriptan in patients under 18 years of age is not recommended. 8.5 Geriatric Use Clinical trials of sumatriptan injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. A cardiovascular evaluation is recommended for geriatric patients who have other cardiovascular risk factors (e.g., diabetes, hypertension, smoking, obesity, strong family history of CAD) prior to receiving Sumavel DosePro [see Warnings and Precautions ( 5.1 ) ]. 8.6 Hepatic Impairment The effect of severe hepatic impairment on Sumavel DosePro metabolism has not been evaluated. Sumavel DosePro is not recommended for use in patients with severe hepatic impairment [see Clinical Pharmacology ( 12.3 ) ].
Pregnancy and lactation
8.3 Nursing Mothers It is not known whether sumatriptan is excreted in human breast milk following subcutaneous administration. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from Sumavel DosePro, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Interactions

7 DRUG INTERACTIONS 7.1 Ergot-Containing Drugs Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. Because these effects may be additive, use of ergotamine-containing or ergot-type medications (like dihydroergotamine or methysergide) and Sumavel DosePro within 24 hours of each other is contraindicated. 7.2 Monoamine Oxidase-A Inhibitors MAO-A inhibitors increase systemic exposure by 2-fold. Therefore, the use of Sumavel DosePro in patients receiving MAO-A inhibitors is contraindicated [see Clinical Pharmacology ( 12.3 ) ]. 7.3 Other 5-HT 1 Agonists Because their vasospastic effects may be additive, co-administration of Sumavel DosePro and other 5-HT1 agonists (e.g., triptans) within 24 hours of each other is contraindicated. 7.4 Selective Serotonin Reuptake Inhibitors/Serotonin Norepinephrine Reuptake Inhibitors and Serotonin Syndrome Cases of serotonin syndrome have been reported during co-administration of triptans and SSRIs, or SNRIs, SNRIs, TCAs, and MAO inhibitors [see Warnings and Precautions ( 5.7 ) ].

More information

Category Value
Authorisation number NDA022239
Orphan designation No
Product NDC 63481-367,63481-229
Date Last Revised 27-06-2016
Type HUMAN PRESCRIPTION DRUG
RXCUI 1657167
Marketing authorisation holder Endo Pharmaceuticals