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Consent for Paxlovid

CONSENT FOR PAXLOVID

1. I acknowledge that my physician has recommended that I receive Paxlovid , which is an investigational medicine used to treat mild to moderate Covid 19 in adults and children 12 years of age or older and weighing at least 88 lbs. I understand that Paxlovid is still being studied and there is limited information about the safety and effectiveness of using this medication for the treatment of mild to moderate COVID 19.

 

2. I understand Paxlovid is NOT an FDA-approved medication and the FDA has authorized the emergency use of Paxlovid for the treatment of COVID-19 under an Emergency Use Authorization (EUA).

3. I acknowledge that I have been provided with the Fact Sheet for Patients, Parents and Caregivers in regards to the medication Paxlovid.

4. I confirm that I have read the Fact Sheet for Patients, Parents and Caregivers for Paxlovid and I have had an opportunity to ask questions in regards to this medication and have had my questions answered to my satisfaction by the healthcare professionals.

5. I understand some medicines may interact with Paxlovid and may cause serious side effects. I understand that it is my responsibility to make sure that my doctor is aware of all of my medications including over the counter medicines, vitamins and herbal supplements as Paxlovid may increase or decrease the levels of multiple other medicines.

I understand that if I am taking any of the medications listed below I should not be taking Paxlovid as it may cause serious or life threatening injuries and I affirm that I am not taking these medications.

? ? ? ANTICONVULSANTS ? Carbamazepine, ? Phenobarbital, ? Phenytoin, ? Primidone ? ? ? ANTI-INFECTIVE AGENTS ? Glecaprevir/pibrentasvir, ? Rifampin, ? Rifapentine ? ? ? CARDIOVASCULAR AGENTS ? Amiodarone, ? Clopidogrel, ? Disopyramide, ? Dofetilide ? Dronedarone, ? plerenone, ? Flecainide, ? Ivabradine, ? Propafenone, ? Quinidine ? ? ? IMMUNOSUPPRESANTS ? Voclosporin ? ? ? NEUROPSYCHIATIRC AGENTS ? Clozapine, ? Lumateperone, ? Lurasidone, ? Midazolam (oral), ? Pimozide PAIN MEDICATIONS ? Meperidine (pethidine) ? ? ? PULMONARY HYPERTENSION MEDICATIONS ? Sildenafil, ? Tadalafil, ? Vardenafil, ? ? ? MISCELLANEOUS ? Bosentan, ? Certain chemotherapeutic agents, ? Ergot derivatives, ? Lumacaftor/ivacaftor, ? St. John?s wort, ? Tolvaptan ? Alfuzosin ? Pethidine, piroxicam, propoxyphene ? Ranolazine ? Amiodarone, dronedarone, flecainide, propafenone, quinidine ? Colchicine ? Lurasidone, pimozide, clozapine ? Dihydroergotamine, ergotamine, methylergonovine ? Lovastatin ,simvastatin, Atorvostatin (STATINS) ? Sildenafil (RevatioŽ) for pulmonary arterial hypertension (PAH) ? Triazolam, oral midazolam, ? Apalutamide, ? Carbamazepine, phenobarbital, phenytoin ? Rifampin, ? St. John?s Wort (hypericum perforatum). ? ? ? ? ? ? Please see link at bottom of this form for medications not listed here

I also understand I should not take Paxlovid if I am allergic to nirmatrelvir, ritonavir or any of the ingredients in Paxlovid.

What if I am pregnant or breastfeeding?

There is no experience treating pregnant women or breastfeeding mothers with PAXLOVID. For a mother and unborn baby, the benefit of taking PAXLOVID may be greater than the risk from the treatment. If you are pregnant, discuss your options and specific situation with your healthcare provider. It is recommended that you use effective barrier contraception or do not have sexual activity while taking PAXLOVID. If you are breastfeeding, discuss your options and specific situation with your healthcare provider.

I understand that Sunil Lalla MD makes no guarantees in regards to the effectiveness of this medication for the treatment of COVID-19 and there may be risks associated with receiving these medications which includes allergic reactions including anaphylaxis, liver problems including loss of appetite, yellowing of your skin and the whites of your eyes, dark colored urine, pale colored stools and itchy skin,abdominal pain, altered sense of taste, diarrhea, high blood pressure and muscle aches. Paxlovid may also interfere with HIV medications. I also understand that there may be other serious side effects that are not known at this time because these medications are still being studied. The effects on pregnant women or breastfeeding mothers are unknown because there is no experience with treating pregnant women or breastfeeding mothers with Paxlovid.

I hereby release On behalf of myself, my heirs and personal representatives, I hereby release and hold harmless Sunil Lalla, MD PA and their staff, agents, successors, divisions, affiliates, subsidiaries, officers, directors, contractors and employees from any and all liabilities or claims whether known or unknown arising out of, in connection with, or in any way related to the administration of Paxlovid. I understand that it is not possible to predict all possible side effects or complications associated with receiving Paxlovid. I understand the risks and benefits associated with taking Paxlovid and have received, read and/or had explained to me the FDA unapproved Use of Paxlovid. I also acknowledge that I have had a chance to ask questions and that such questions were answered to my satisfaction.

 
Please print your name in the signature field. Typing your name will be counted as an electronic signature. I am the individual who has typed their name actually signed the document.

Please verify medications at the following website for interactions: https://covid19-druginteractions.org/checker

https://www.fda.gov/media/155051/download

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