Tadalafil
You must always read this safety information prior to starting this medication and whenever you get a refill. There may be new information. This information is not a substitute for discussing your medical condition or treatment with your healthcare provider. It is only available if prescribed by a licensed physician partner through BraveRx who will determine if treatment is suitable.
What I need to know about Tadalafil:
Tadalafil is a phosphodiesterase type 5 (PDE5) inhibitor FDA-approved for treating erectile dysfunction (ED) and pulmonary arterial hypertension (PAH). It works by increasing blood flow to the penis to help achieve and maintain an erection.[14][17]
Absolute Contraindications - DO NOT use tadalafil if you:
- Are allergic to tadalafil or its ingredients
- Are taking any form of nitrate medication for chest pain or heart problems[14][19]
- Are taking guanylate cyclase stimulators like riociguat[17]
Drug Interactions - DO NOT use tadalafil if you take:
- Nitrate medications like nitroglycerin isosorbide or recreational "poppers"[19]
- Guanylate cyclase stimulators like riociguat[17]
- Certain HIV protease inhibitors like ritonavir without dose adjustments[17]
Serious Side Effects - STOP treatment and seek emergency care if you experience:
- Sudden vision loss in one or both eyes[10][18]
- Sudden decrease or loss of hearing[14][18]
- Erection lasting more than 4 hours (priapism)[10][14][18]
Common Side Effects - Talk to your provider if you experience:
- Headache flushing indigestion muscle aches back pain nasal congestion[10][14]
Tadalafil has a Boxed Warning for embryo-fetal toxicity. Females must enroll in a special risk program before taking tadalafil products containing macitentan.[13]
This is not a complete list of side effects. Refer to the full prescribing information. Report negative side effects to the FDA at www.fda.gov/medwatch or 1-800-FDA-1088.[14]
Vardenafil
You must always read this safety information prior to starting this medication and whenever you get a refill. There may be new information. This information is not a substitute for discussing your medical condition or treatment with your healthcare provider. It is only available if prescribed by a licensed physician partner through BraveRx who will determine if treatment is suitable.
What I need to know about Vardenafil:
Vardenafil is a PDE5 inhibitor FDA-approved for treating erectile dysfunction (ED). It works by increasing blood flow to the penis.[4][7][10]
Absolute Contraindications - DO NOT use vardenafil if you:
- Are allergic to vardenafil
- Are taking nitrate medications for angina or riociguat[10][14][18]
- Have phenylketonuria and are prescribed the rapidly disintegrating tablets (contain aspartame)[10]
- Have fructose intolerance and are prescribed the rapidly disintegrating tablets (contain sorbitol)[10]
Drug Interactions - DO NOT use vardenafil if you take:
- Nitrate medications like nitroglycerin or recreational "poppers"[10][14]
- Riociguat for pulmonary hypertension[10]
Serious Side Effects - STOP treatment and seek emergency care if you experience:
- Erection lasting more than 4 hours (priapism)[10][18]
- Sudden vision loss in one or both eyes[10][18]
- Sudden decrease or loss of hearing[10][18]
Common Side Effects - Talk to your provider if you experience:
- Headache flushing stuffy/runny nose indigestion back pain[10][18]
Vardenafil may cause low blood pressure when taken with alpha-blockers for high blood pressure or BPH. It can also increase the blood pressure lowering effects of anti-hypertensives.[14]
This is not a complete list of side effects. Refer to the full prescribing information. Report negative side effects to the FDA at www.fda.gov/medwatch or 1-800-FDA-1088.[10]
Apomorphine
You must always read this safety information prior to starting this medication and whenever you get a refill. There may be new information. This information is not a substitute for discussing your medical condition or treatment with your healthcare provider. It is only available if prescribed by a licensed physician partner through Brave Rx who will determine if treatment is suitable.
What I need to know about Apomorphine:
Apomorphine is a non-ergoline dopamine agonist FDA-approved for the acute intermittent treatment of "off" episodes associated with advanced Parkinson's disease.[6][11][15]
Absolute Contraindications - DO NOT use apomorphine if you:
- Are allergic to apomorphine its ingredients or sodium metabisulfite
- Are taking 5HT3 antagonist anti-emetics like ondansetron granisetron etc.[6][15]
Drug Interactions - DO NOT use apomorphine if you take:
- 5HT3 antagonist anti-emetics like ondansetron granisetron dolasetron palonosetron alosetron[6][15]
Serious Side Effects - STOP treatment and seek emergency care if you experience:
- Severe nausea/vomiting confusion hallucinations[6][15]
- Low blood pressure dizziness fainting[6][15]
- Trouble breathing chest pain[15]
Common Side Effects - Talk to your provider if you experience:
- Yawning drowsiness involuntary movements runny nose nausea[11][15]
This is not a complete list of side effects. Refer to the full prescribing information. Report negative side effects to the FDA at www.fda.gov/medwatch or 1-800-FDA-1088.[15]
L-Citrulline
You must always read this safety information prior to starting this medication and whenever you get a refill. There may be new information. This information is not a substitute for discussing your medical condition or treatment with your healthcare provider. It is only available if prescribed by a licensed physician partner through BraveRx who will determine if treatment is suitable.
What I need to know about L-Citrulline:
L-Citrulline is a non-essential amino acid used as a medical food for urea cycle disorders and sometimes taken as a dietary supplement.[3][5][9]
Absolute Contraindications - DO NOT use L-citrulline if you:
- Are allergic to L-citrulline
Drug Interactions - DO NOT use L-citrulline if you take:
- Nitrate medications for heart disease
- Blood pressure medications (may increase hypotensive effects)
Serious Side Effects - Seek medical care if you experience:
- Severe drop in blood pressure, dizziness, fainting[5]
- Nausea diarrhea, bloating, heartburn[9]
Common Side Effects:
- No major common side effects reported from studies using up to 9g/day for 16 days.[5][9]
L-Citrulline has not been associated with serious safety concerns in studies but may interact with certain medications. Avoid use in pregnancy/breastfeeding due to lack of data.[5][9]
This is not a complete list of side effects or interactions. Refer to the full product information. Report negative side effects to the FDA at www.fda.gov/medwatch or 1-800-FDA-1088.[5][9]
Citations
[1] https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210875.pdf
[2] https://www.usp.org/sites/default/files/usp/document/our-work/DS/dsc_dec2016.pdf
[3] https://fda.report/media/109619/FDA-Presentations-for-the-November-20-21--2017-Meeting-of-the-Pharmacy-Compounding-Advisory-Committee.pdf
[4] https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tadalafil_oral%20tablet_NDA%20022332%20and%20NDA%2021368_RV08-17.pdf
[5] https://www.verywellhealth.com/citrulline-4774848
[6] https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021264s010lbl.pdf
[7] https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200179Orig1s000ClinPharmR.pdf
[8] https://www.empr.com/home/news/drugs-in-the-pipeline/fda-accepts-resubmitted-nda-for-apomorphine-infusion-device/
[9] https://www.webmd.com/vitamins-and-supplements/l-citrulline-uses-and-risks
[10] https://medlineplus.gov/druginfo/meds/a603035.html
[11] https://www.fda.gov/drugs/drug-safety-and-availability/approved-first-generic-apokyn-injection-cartridges-requires-separately-packaged-pen
[12] https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210875lbl.pdf
[13] https://www.ajmc.com/view/fda-approves-macitentan-tadalafil-combination-tablet-for-pulmonary-arterial-hypertension
[14] https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021400s010lbl.pdf
[15] https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021264s022lbl.pdf
[16] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2643112/
[17] https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214522s000lbl.pdf
[18] https://www.mayoclinic.org/drugs-supplements/vardenafil-oral-route/proper-use/drg-20067107?p=1
[19] https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022332s007lbl.pdf
[20] https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021368s011lbl.pdf