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Rx Item-DELSTRIGO doravirine/lamivudine/tenofovie disodium ORAL TABLET 100-300 M

RX785337Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Rx Item-DELSTRIGO doravirine/lamivudine/tenofovie disodium ORAL TABLET 100-300 M

$2778.12$2524.13

NDC No.6500701 00006-5007-01 0006-5007-01 0006500701 00006500701 UPC/GTIN No.3-00065-00701-4 300065007014 300065-007014 MPN No.500701 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, NP, Optometrist, & Pharmacist, PA, Physical Therapist, Podiatrist, Research Co., Uni., VA, Vet & Wholesalers In Scope Of their Practice Can Order Rx Item.

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for: HIV Infection

Delstrigo (doravirine, lamivudine and tenofovir disoproxil fumarate) a non-nucleoside reverse transcriptase inhibitor (NNRTI) and nucleoside analogue reverse transcriptase inhibitors combination indicated for the treatment of HIV-1 infection. Each DELSTRIGO tablet contains 100 mg of doravirine, 300 mg of lamivudine, and 300 mg of tenofovir disoproxil fumarate (equivalent to 245 mg of tenofovir disoproxil), is yellow, oval-shaped, film-coated, and is debossed with the corporate logo and 776 on one side and plain on the other side. Each bottle contains 30 tablets (NDC 0006-5007-01) and silica gel desiccants, and is closed with a child-resistant closure.

Store DELSTRIGO in the original bottle. Keep the bottle tightly closed to protect from moisture. Do not remove the desiccants.

Store DELSTRIGO at 20�C to 25�C (68�F to 77�F); excursions permitted to 15�C to 30�C (59�F to 86�F) [see USP Controlled Room Temperature]. These highlights do not include all the information needed to use DELSTRIGO safely and effectively. See full prescribing information for DELSTRIGO.

DELSTRIGO� (doravirine, lamivudine, and tenofovir disoproxil fumarate) tablets, for oral use
Initial U.S. Approval: 2018
WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B
See full prescribing information for complete boxed warning.

Severe acute exacerbations of hepatitis B (HBV) have been reported in patients coinfected with HIV-1 and HBV who have discontinued lamivudine or tenofovir disoproxil fumarate (TDF), two of the components of DELSTRIGO. Closely monitor hepatic function in these patients. If appropriate, initiation of anti-hepatitis B therapy may be warranted. (5.1)
RECENT MAJOR CHANGES
Indications and Usage (1) 09/2019
Warnings and Precautions,
Immune Reconstitution Syndrome (5.5) 09/2019
INDICATIONS AND USAGE

DELSTRIGO is a three-drug combination of doravirine (a non-nucleoside reverse transcriptase inhibitor [NNRTI]), lamivudine, and tenofovir disoproxil fumarate (both nucleoside analogue reverse transcriptase inhibitors) and is indicated as a complete regimen for the treatment of HIV-1 infection in adult patients:

with no antiretroviral treatment history, OR
to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of DELSTRIGO. (1)

DOSAGE AND ADMINISTRATION

Testing: Prior to or when initiating DELSTRIGO, test for HBV infection. Prior to or when initiating DELSTRIGO, and during treatment with DELSTRIGO, on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus. (2.1)
Recommended dosage: One tablet taken orally once daily with or without food in adult patients. (2.2)
Renal impairment: Not recommended in patients with estimated creatinine clearance below 50 mL per minute. (2.3)
Dosage adjustment with rifabutin: Take one tablet of DELSTRIGO once daily, followed by one tablet of doravirine 100 mg (PIFELTRO) approximately 12 hours after the dose of DELSTRIGO. (2.4)

DOSAGE FORMS AND STRENGTHS

Tablets: 100 mg of doravirine, 300 mg of lamivudine, and 300 mg of tenofovir disoproxil fumarate. (3)

CONTRAINDICATIONS

DELSTRIGO is contraindicated when co-administered with drugs that are strong cytochrome P450 (CYP)3A enzyme inducers as significant decreases in doravirine plasma concentrations may occur, which may decrease the effectiveness of DELSTRIGO. (4)
DELSTRIGO is contraindicated in patients with a previous hypersensitivity reaction to lamivudine.

WARNINGS AND PRECAUTIONS

New onset or worsening renal impairment: Prior to or when initiating DELSTRIGO, and during treatment with DELSTRIGO, on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. Avoid administering DELSTRIGO with concurrent or recent use of nephrotoxic drugs. (5.2)
Bone loss and mineralization defects: Consider monitoring BMD in patients with a history of pathologic fracture or other risk factors of osteoporosis or bone loss. (5.4)
Monitor for Immune Reconstitution Syndrome. (5.5)

ADVERSE REACTIONS

Most common adverse reactions (incidence greater than or equal to 5%, all grades) are dizziness, nausea, and abnormal dreams. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS

Because DELSTRIGO is a complete regimen, co-administration with other antiretroviral medications for treatment of HIV-1 infection is not recommended. (7.1)
Consult the full prescribing information prior to and during treatment for important potential drug-drug interactions. (4, 5.3, 7)

USE IN SPECIFIC POPULATIONS

Lactation: Breastfeeding is not recommended due to the potential for HIV-1 transmission. (8.2)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 10/2019

RX785337
Rx Item-DELSTRIGO doravirine/lamivudine/
RX785337

Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
Rx Item-DELSTRIGO doravirine/lamivudine/
Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
AmericanPharmaWholesale.com
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop