Important Safety Information for PEAK Fusion

01 STOP! You Cannot Take This Medication If

02 STOP Taking This Medication and Seek Immediate Medical Attention If

03 You NEED to Tell Your Doctor BEFORE Taking This Medication If

• You are allergic to this drug or any part of this drug.
• You have pulmonary veno-occlusive disease (PVOD).
• You have retinitis pigmentosa.
• You have sickle cell disease.
• You use "poppers" that contain nitrites.
• You are taking any of these drugs: Cobicistat, isosorbide dinitrate, isosorbide mononitrate, nitroglycerin, riociguat, ritonavir, vericiguat, itraconazole, or ketoconazole.
• You are taking a 5HT3 antagonist / anti-nausea medication such as ondansetron (Zofran), granisetron, dolasetron, palonosetron, or alosetron — combining these with the apomorphine in PEAK Fusion can cause severe low blood pressure and loss of consciousness.
• You are taking any dopamine antagonist or antipsychotic (such as haloperidol, risperidone, olanzapine, or metoclopramide) — these can block the effect of apomorphine.
• You have low blood pressure, orthostatic hypotension, or a history of fainting.
• You have Parkinson's disease or are taking any Parkinson's medications.
• You have a history of nausea, vomiting, or gastrointestinal disorders.
• You are taking another drug that has the same active drug in it.
• You are taking another drug for erectile dysfunction.
• You have been told that you are not healthy enough to have sex, or you have had a heart attack in the last 90 days, chest pain during sex, heart failure, abnormal heartbeat, blood pressure problems, or a stroke in the last 6 months.
• You are of female gender or a child.
• You have a history of a misshapen penis (Peyronie's disease).
• You have ever had an erection that was painful or lasted more than 4 hours.
• You have a history of any of the following medical problems: gastrointestinal ulcers, liver conditions, kidney problems or dialysis, bleeding, anemia, blood cancers such as leukemia or myeloma, vision loss, or NAION.

04 Tell Your Healthcare Provider If You Are Taking Any of These Drugs

Any medications, prescription and over-the-counter, including any supplements, vitamins, or herbals. It is especially important to let your provider know if you are taking any of the following:

• Nitrates.
• Guanylate cyclase stimulators (examples: Riociguat, Adempas).
• Alpha blockers (examples: Hytrin/terazosin, Flomax/tamsulosin, Cardura/doxazosin mesylate, Minipress/prazosin, Uroxatral/alfuzosin, Jalyn/dutasteride and tamsulosin, Rapaflo/silodosin).
• Protease inhibitors used for HIV treatment (examples: Norvir/ritonavir, Crixivan/indinavir sulfate, Fortovase or Invirase/saquinavir, Reyataz/atazanavir sulfate).
• Antifungals (examples: Nizoral/ketoconazole, Sporanox/itraconazole).
• Antibiotics or antibacterials.
• 5HT3 anti-nausea medications (examples: Zofran/ondansetron, Kytril/granisetron, Anzemet/dolasetron, Aloxi/palonosetron, Lotronex/alosetron) — do not combine with PEAK Fusion: severe hypotension and loss of consciousness have been reported.
• Dopamine antagonists and antipsychotics (examples: haloperidol, risperidone, olanzapine, metoclopramide) — these can block the apomorphine component.
• Other dopamine agonists or Parkinson's medications (examples: pramipexole, ropinirole, levodopa).
• Any medications to treat blood pressure, erectile dysfunction, or pulmonary artery hypertension (such as Revatio or Adcirca, which contain the same main ingredients found in PEAK Fusion), or any medication containing apomorphine (such as Apokyn).

05 Other Things You Should Know About This Medication

• Talk with your doctor before you drink alcohol while on this medication.
• This drug does not protect you against sexually transmitted diseases (including HIV) or pregnancy.
• This medicine is not a cure for erectile dysfunction and does not have an effect on libido.

06 Possible Side Effects When Taking This Medication

• Headache, dizziness, imbalance, drowsiness, or passing out.
• Nausea, vomiting, or upset stomach — most commonly linked to the apomorphine component; often reduces with continued use.
• Yawning, sweating, or hot flashes.
• Back pain, muscle pain, arm and leg pain.
• Indigestion, acid reflux.
• Facial flushing.
• Stuffy or runny nose, sinus congestion.
• Rash, hives, itching; red, swollen, blistered, or peeling skin.
• Pressure or pain in the chest, chest tightness, wheezing, trouble breathing.
• Fast or abnormal heartbeat.
• Low blood pressure or orthostatic hypotension (dizziness on standing) — apomorphine and PDE5 inhibitors can both lower blood pressure; the risk is additive.
• Stroke-like symptoms such as weakness, trouble speaking or thinking, face drooping.
• Change or loss of eyesight or blurriness.
• Throat, mouth, face, lips, or tongue swelling; hoarseness; difficulty swallowing.
• Ringing in the ears, hearing loss, changes in hearing.
• Swelling of extremities.
• Bleeding, bruising.
• Sudden urges (gambling, sexual, spending, binge-eating) — reported with dopamine agonists like apomorphine; tell your provider if any new compulsive behavior develops.
• Painful erection or an erection that lasts longer than 4 hours.