KYNMOBI Sublingual film Ref.[10859] Active ingredients: Apomorphine

2.1 Important Administration Instructions

Dose initiation should be supervised by a healthcare provider [see Dosage and Administration (2.3)].

KYNMOBI must be administered whole. Do not to cut, chew, or swallow KYNMOBI. KYNMOBI will disintegrate in about 3 minutes.

Because of the high incidence of nausea and vomiting with KYNMOBI when administered at recommended doses, an antiemetic (e.g., trimethobenzamide 300 mg three times a day), beginning 3 days prior to the initial dose of KYNMOBI, is recommended. Treatment with the antiemetic should only be continued as long as necessary to control nausea and vomiting, and generally no longer than two months after initiation of treatment with KYNMOBI [see Contraindications (4) and Warnings and Precautions (5.1)].

Based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron, the concomitant use of apomorphine with drugs of the 5HT3 antagonist class including antiemetics (for example, ondansetron, granisetron, dolasetron, palonosetron) and alosetron are contraindicated [see Contraindications (4)].

2.2 Dosing Information

The dose range for KYNMOBI is 10 mg to 30 mg per dose, administered sublingually, as needed, for the acute, intermittent treatment of “off” episodes.

Doses should be separated by at least 2 hours. If a single dose of KYNMOBI is ineffective for a particular “off” episode, a second dose should not be given for that “off” episode. The efficacy or safety of administering a second dose for a single “off” episode has not been studied.

Do not administer more than 5 doses per day.

The maximum single dose of KYNMOBI is 30 mg.

2.3 Dose Titration

The initial dose is 10 mg. Dose initiation should occur when the patient is in an “off” state and in a setting where a healthcare provider can monitor blood pressure and pulse. In clinical studies of KYNMOBI, the “off” state was achieved by instructing patients to not take their regular morning dose of carbidopa/levodopa or any other adjunctive Parkinson’s disease medications, and to take their last dose of carbidopa/levodopa and any other adjunctive Parkinson’s disease medications no later than midnight the night before [see Clinical Studies (14)].

If the patient tolerates the 10 mg dose, and responds adequately, the starting dose should be 10 mg, used on an as needed basis, up to 5 times per day, to treat “off” episodes. If the dose is tolerated but the response is insufficient, the patient’s usual Parkinson’s disease medications should be resumed and up-titration with KYNMOBI continued generally within 3 days. Increase dosage by increments of 5 mg and assess response. Continue to titrate in a similar manner, under the supervision of a healthcare provider, until an effective and tolerable dose is achieved [see Dosage and Administration (2.2) and Clinical Studies (14)].

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].

Keep KYNMOBI in the foil pouch until ready to use.