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ODEFSEY
Overview
What is ODEFSEY?
ODEFSEY (emtricitabine, rilpivirine, and tenofovir alafenamide) is a fixed-dose combination tablet containing emtricitabine (FTC), rilpivirine (RPV), and tenofovir alafenamide (TAF) for oral administration.
Each tablet contains 200 mg of FTC, 25 mg of RPV (equivalent to 27.5 of rilpivirine hydrochloride) and 25 mg of TAF (equivalent to 28 mg of tenofovir alafenamide fumarate) and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 20, and povidone. The tablets are film-coated with a coating material containing iron oxide black, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.
What does ODEFSEY look like?
What are the available doses of ODEFSEY?
Tablets: 200 mg of FTC, 25 mg of RPV and 25 mg of TAF. ()
What should I talk to my health care provider before I take ODEFSEY?
How should I use ODEFSEY?
ODEFSEY is indicated as a complete regimen for the treatment of HIV-1 infection in patients 12 years of age and older as initial therapy in those with no antiretroviral treatment history with HIV-1 RNA less than or equal to 100,000 copies per mL; or to replace a stable antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) for at least six months with no history of treatment failure and no known substitutions associated with resistance to the individual components of ODEFSEY
Prior to initiation of ODEFSEY, patients should be tested for hepatitis B virus infection .
It is recommended that serum creatinine, serum phosphorus, estimated creatinine clearance, urine glucose, and urine protein should be assessed before initiating ODEFSEY and during therapy in all patients as clinically appropriate
What interacts with ODEFSEY?
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What are the warnings of ODEFSEY?
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What are the precautions of ODEFSEY?
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What are the side effects of ODEFSEY?
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What should I look out for while using ODEFSEY?
ODEFSEY is contraindicated when coadministered with the following drugs; coadministration may result in loss of virologic response and possible resistance to ODEFSEY or to the class of NNRTIs :
ODEFSEY is not approved for the treatment of chronic hepatitis B virus (HBV) infection, and the safety and efficacy of ODEFSEY have not been established in patients coinfected with human immunodeficiency virus-1 (HIV-1) and HBV. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of ODEFSEY.
Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue ODEFSEY. If appropriate, initiation of anti-hepatitis B therapy may be warranted .
What might happen if I take too much ODEFSEY?
No data are available on overdose of ODEFSEY in patients. If overdose occurs, monitor the patient for evidence of toxicity. Treatment of overdose with ODEFSEY consists of general supportive measures including monitoring of vital signs and ECG (QT interval) as well as observation of the clinical status of the patient.
How should I store and handle ODEFSEY?
Store under normal lighting conditions at 20-25°C (68-77°F); excursions permitted to 15-30°C (59- 86°F) ODEFSEY tablets are gray, capsule-shaped, and film coated with "GSI" debossed on one side and "255" on the other side. Each bottle contains 30 tablets (NDC 61958-2101-1), a silica gel desiccant, and a polyester coil, and is closed with a child-resistant closure.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
ODEFSEY is a fixed dose combination of antiretroviral drugs emtricitabine, rilpivirine, and tenofovir alafenamide .
Non-Clinical Toxicology
ODEFSEY is contraindicated when coadministered with the following drugs; coadministration may result in loss of virologic response and possible resistance to ODEFSEY or to the class of NNRTIs :ODEFSEY is not approved for the treatment of chronic hepatitis B virus (HBV) infection, and the safety and efficacy of ODEFSEY have not been established in patients coinfected with human immunodeficiency virus-1 (HIV-1) and HBV. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of ODEFSEY.
Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue ODEFSEY. If appropriate, initiation of anti-hepatitis B therapy may be warranted .
FUROSEMIDE TABLET may increase the ototoxic potential of aminoglycoside antibiotics, especially in the presence of impaired renal function. Except in life-threatening situations, avoid this combination.
FUROSEMIDE TABLET should not be used concomitantly with ethacrynic acid because of the possibility of ototoxicity. Patients receiving high doses of salicylates concomitantly with FUROSEMIDE TABLET, as in rheumatic disease, may experience salicylate toxicity at lower doses because of competitive renal excretory sites.
There is a risk of ototoxic effects if cisplatin and FUROSEMIDE TABLET are given concomitantly. In addition, nephrotoxicity of nephrotoxic drugs such as cisplatin may be enhanced if FUROSEMIDE TABLET is not given in lower doses and with positive fluid balance when used to achieve forced diuresis during cisplatin treatment.
FUROSEMIDE TABLET has a tendency to antagonize the skeletal muscle relaxing effect of tubocurarine and may potentiate the action of succinylcholine.
Lithium generally should not be given with diuretics because they reduce lithium’s renal clearance and add a high risk of lithium toxicity.
FUROSEMIDE TABLET combined with angiotensin converting enzyme inhibitors or angiotensin II receptor blockers may lead to severe hypotension and deterioration in renal function, including renal failure. An interruption or reduction in the dosage of FUROSEMIDE, angiotensin converting enzyme inhibitors, or angiotensin receptor blockers may be necessary.
Potentiation occurs with ganglionic or peripheral adrenergic blocking drugs.
FUROSEMIDE TABLET may decrease arterial responsiveness to norepinephrine. However, norepinephrine may still be used effectively.
Simultaneous administration of sucralfate and FUROSEMIDE TABLET may reduce the natriuretic and antihypertensive effects of FUROSEMIDE TABLET. Patients receiving both drugs should be observed closely to determine if the desired diuretic and/or antihypertensive effect of FUROSEMIDE TABLET is achieved. The intake of FUROSEMIDE TABLET and sucralfate should be separated by at least two hours.
In isolated cases, intravenous administration of FUROSEMIDE TABLET within 24 hours of taking chloral hydrate may lead to flushing, sweating attacks, restlessness, nausea, increase in blood pressure, and tachycardia. Use of FUROSEMIDE TABLET concomitantly with chloral hydrate is therefore not recommended.
Phenytoin interferes directly with renal action of FUROSEMIDE TABLET. There is evidence that treatment with phenytoin leads to decrease intestinal absorption of FUROSEMIDE TABLET, and consequently to lower peak serum furosemide concentrations.
Methotrexate and other drugs that, like FUROSEMIDE TABLET, undergo significant renal tubular secretion may reduce the effect of FUROSEMIDE TABLET. Conversely, FUROSEMIDE TABLET may decrease renal elimination of other drugs that undergo tubular secretion. High-dose treatment of both FUROSEMIDE TABLET and these other drugs may result in elevated serum levels of these drugs and may potentiate their toxicity as well as the toxicity of FUROSEMIDE TABLET.
FUROSEMIDE TABLET can increase the risk of cephalosporin-induced nephrotoxicity even in the setting of minor or transient renal impairment.
Concomitant use of cyclosporine and FUROSEMIDE TABLET is associated with increased risk of gouty arthritis secondary to FUROSEMIDE TABLET- induced hyperurecemia and cyclosporine impairment of renal urate excretion.
High doses (>80 mg) of furosemide may inhibit the binding of thyroid hormones to carrier proteins and result in transient increase in free thyroid hormones, followed by an overall decrease in total thyroid hormone levels.
One study in six subjects demonstrated that the combination of furosemide and acetylsalicylic acid temporarily reduced creatinine clearance in patients with chronic renal insufficiency. There are case reports of patients who developed increased BUN, serum creatinine and serum potassium levels, and weight gain when furosemide was used in conjunction with NSAIDs.
Literature reports indicate that coadministration of indomethacin may reduce the natriuretic and antihypertensive effects of FUROSEMIDE TABLET (furosemide) in some patients by inhibiting prostaglandin synthesis. Indomethacin may also affect plasma renin levels, aldosterone excretion, and renin profile evaluation. Patients receiving both indomethacin and FUROSEMIDE TABLET should be observed closely to determine if the desired diuretic and/or antihypertensive effect of FUROSEMIDE TABLET is achieved.
Patients with HIV-1 should be tested for the presence of hepatitis B virus (HBV) before initiating antiretroviral therapy . ODEFSEY is not approved for the treatment of chronic HBV infection, and the safety and efficacy of ODEFSEY have not been established in patients coinfected with HIV-1 and HBV.
Severe acute exacerbations of hepatitis B (e.g., liver decompensation and liver failure) have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing FTC and/or TDF, and may occur with discontinuation of ODEFSEY. Patients coinfected with HIV-1 and HBV who discontinue ODEFSEY should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment. If appropriate, initiation of antihepatitis B therapy may be warranted, especially in patients with advanced liver disease or cirrhosis, since post treatment exacerbation of hepatitis may lead to hepatic decompensation and liver failure.
The following adverse reactions are discussed in other sections of the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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