Elevated levels of dalfampridine increase the risk of seizures. Read this Instructions for Use before giving a dose of medicine. Do not give 2 doses at the same time or give more than your healthcare provider has prescribed. Antiviral Activity in Combination with Other Antiviral Agents. Each film-coated tablet contains dolutegravir sodium equivalent to 50 mg of dolutegravir. Dolutegravir has a terminal half-life of approximately 14 hours and an apparent clearance (CL/F) of 1.0 L per hour based on population pharmacokinetic analyses. In SINGLE, 833 subjects were randomized and received at least 1 dose of either Tivicay 50 mg with fixed-dose abacavir sulfate and lamivudine (EPZICOM) once daily or fixed-dose efavirenz/emtricitabine/tenofovir (ATRIPLA) once daily (study treatment was blinded through Week 96 and open-label from Week 96 through Week 144). Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). (n = 405), Tivicay Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk. Duration of therapy: 28 days Tivicay and Tivicay PD are contraindicated in patients who have experienced a previous hypersensitivity reaction to dolutegravir. Consider the potential for drug interactions prior to and during therapy with Tivicay or Tivicay PD; review concomitant medications during therapy with Tivicay or Tivicay PD; and monitor for the adverse reactions associated with the concomitant drugs. Do not give Tivicay or Tivicay PD to other people, even if they have the same symptoms you have. Generic name: dolutegravir sodium Dosage form: tablet, film coated Drug class: Integrase strand transfer inhibitor Medically reviewed by Drugs.com. The potential benefits of taking dalfampridine concurrently with Tivicay or Tivicay PD should be considered against the risk of seizures in these patients. -In combination with rilpivirine, as a complete regimen, for the treatment of HIV-1 infection to replace a stable antiretroviral regimen in adults who are virologically-suppressed (HIV-1 RNA less than 50 copies/mL) for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to either drug. Dolutegravir doses are based on weight in children. Usual Adult Dose for Nonoccupational Exposure: US CDC Recommendations: 50 mg orally once a day Tivicay PD tablets for oral suspension are for use in children and infants aged at least four weeks and weighing at least 6 pounds (3 kilograms). This dose is associated with an exposure that is approximately 24 times higher than the exposure in humans at the maximum recommended dose. Tivicay (dolutegravir) is an integrase strand transfer inhibitor (INSTI) used in combination with other antiretroviral agents to treat human immunodeficiency virus type 1 (HIV-1) infection in adults and children aged 12 years and older. Common side effects include trouble sleeping, feeling tired, diarrhea, high blood sugar, and headache. In vivo, dolutegravir inhibits tubular secretion of creatinine by inhibiting OCT2 and potentially MATE1. After baseline and placebo adjustment, the maximum mean QTc change based on Fridericia correction method (QTcF) for dolutegravir was 2.4 msec (1-sided 95% upper CI: 4.9 msec). Do not use Tivicay or Tivicay PD for a condition for which it was not prescribed. The proportion of subjects who were non-responders (HIV-1 RNA greater than or equal to 50 copies per mL) at Week 96 was 8% and 12% in the arms receiving Tivicay and darunavir + ritonavir, respectively; no virologic data were available for 12% and 21% for subjects treated with Tivicay and darunavir + ritonavir, respectively. Side-by-side tabulation is to simplify presentation; direct comparisons across trials should not be made due to differing trial designs. There was no treatment-emergent resistance to dolutegravir or to the NRTI background. Refer to the prescribing information for metformin for assessing the benefit and risk of concomitant use of Tivicay or Tivicay PD and metformin. In the pooled analyses, the proportion of subjects receiving Tivicay plus rilpivirine who discontinued treatment due to an adverse event through Week 148 was 8%. Laboratory abnormalities observed in the FLAMINGO trial were generally consistent with observations in SPRING-2 and SINGLE. See full prescribing information for TIVICAY. Population pharmacokinetic analysis using data from SAILING and VIKING-3 trials indicated that mild and moderate renal impairment had no clinically relevant effect on the exposure of dolutegravir. In general, caution should be exercised in the administration of Tivicay in elderly patients reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see Clinical Pharmacology (12.3)]. Therefore, Tivicay and Tivicay PD are not recommended for use in patients with severe hepatic impairment [see Clinical Pharmacology (12.3)]. ---This drug should not be used in nonpregnant females of childbearing potential who are sexually active or have been sexually assaulted and who are not using effective contraception; and, Instruct patients and caregivers to store the Tivicay 10-mg tablets and Tivicay PD 5-mg tablets for oral suspension in the original package, keep the bottle tightly closed, and protect from moisture. It is unknown if baseline characteristics were balanced between the study treatment groups. SINGLE: Treatment differences were maintained across baseline characteristics including baseline viral load, CD4+ cell count, age, gender, and race. In vitro, dolutegravir inhibited the basolateral renal transporters, organic anion transporter (OAT) 1 (IC50 = 2.12 microM) and OAT3 (IC50 = 1.97 microM). In SPRING-2, 822 subjects were randomized and received at least 1 dose of either Tivicay 50 mg once daily or raltegravir 400 mg twice daily, both in combination with fixed-dose dual nucleoside reverse transcriptase inhibitor (NRTI) treatment (either abacavir sulfate and lamivudine [EPZICOM] or emtricitabine/tenofovir [TRUVADA]). Amino acid substitutions E92Q, G118R, S153F or Y, G193E or R263K emerged in different passages and conferred decreased susceptibility to dolutegravir of up to 4-fold. VIKING-3 examined the effect of Tivicay 50 mg twice daily over 7 days of functional monotherapy, followed by OBT with continued treatment of Tivicay 50 mg twice daily. Dolutegravir is metabolized by UGT1A1 with some contribution from CYP3A. Virologically Suppressed Subjects: SWORD-1 and SWORD-2 are identical trials in virologically suppressed subjects receiving 2 NRTIs plus either an INSTI, an NNRTI, or a PI, that switched to dolutegravir plus rilpivirine (n = 513) or remained on their current antiviral regimen (n = 511). Allow the tablet to disperse (it will not dissolve completely). Do not remove desiccant. -If switching from the tablet formulation to the tablets for oral suspension formulation, the recommended dosage for Tablets for Oral Suspension should be followed. Dolutegravir is an HIV-1 antiretroviral agent [see Microbiology (12.4)]. Dispose of them using your local household waste guidelines. The adjusted difference between treatment arms and 95% CI was 46.9 cells per mm3 (15.6 cells per mm3, 78.2 cells per mm3) (adjusted for pre-specified stratification factors: baseline HIV-1 RNA, and baseline CD4+ cell count). Keep Tivicay PD and all medicines out of the reach of children. There was no treatment-emergent resistance to dolutegravir, abacavir, or lamivudine. For children taking Tivicay PD tablets for oral suspension, read the Instructions for Use that come with the medicine for detailed instructions on how to prepare a dose. Therapy-naive or therapy-experienced INSTI-naive patients when coadministered with certain UGT1A or CYP450 3A inducers: 50 mg orally twice a day Two virologic failure subjects in SINGLE had treatment-emergent G/D/E193D and G193G/E integrase substitutions at Week 84 and Week 108, respectively, and 1 subject with 275 copies per mL HIV-1 RNA had a treatment-emergent Q157Q/P integrase substitution detected at Week 24. However, no dosage adjustment is necessary for treatment-nave or treatment-experienced and INSTI-nave patients with mild, moderate, or severe renal impairment or for INSTI-experienced patients (with certain INSTI-associated resistance substitutions or clinically suspected INSTI resistance) with mild or moderate renal impairment. Because of the potential for (1) HIV1 transmission (in HIV-negative infants), (2) developing viral resistance (in HIV-positive infants), and (3) adverse reactions in a breastfed infant similar to those seen in adults, instruct mothers not to breastfeed if they are receiving dolutegravir. Throw away the rest of the prepared medicine and make a new dose. NDC 49702-228-13. In addition, Grade 1 insomnia was reported by 1% and less than 1% of subjects receiving Tivicay and raltegravir, respectively, in SPRING-2; whereas in SINGLE the rates were 7% and 4% for Tivicay and ATRIPLA, respectively. Symptoms of ED include. Dosing or regimen recommendations as a result of established and other potentially significant drug-drug interactions with Tivicay are provided in Table 8 [see Dosage and Administration (2.2), Drug Interactions (7.3)]. Overall, the safety data in pediatric subjects from the IMPAACT P1093 trial were comparable to those observed in adults [see Adverse Reactions (6.1)]. Allow parts to dry completely before reassembling and storing. This increases blood flow and allows you to get an erection in response to sexual . Clinical status, including liver aminotransferases, should be monitored and appropriate therapy initiated. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. The purpose of this registry is to collect information about the health of you and your baby. Uses. 25 mg: Each tablet contains 25 mg of dolutegravir (as dolutegravir sodium). Keep the bottle tightly closed and protected from moisture. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Treatment-Nave Subjects: The safety assessment of Tivicay in HIV1infected treatment-nave subjects is based on the analyses of data from 2 international, multicenter, double-blind trials, SPRING-2 (ING113086) and SINGLE (ING114467) and data from the international, multicenter, open-label FLAMINGO (ING114915) trial. The relative bioavailability of Tivicay PD is approximately 1.6-fold higher than Tivicay; therefore, the 2 dosage forms are not interchangeable on a milligram-per-milligram basis [see Dosage and Administration (2.3)]. Thirty-one percent of the total oral dose was excreted in urine, represented by an ether glucuronide of dolutegravir (18.9% of total dose), a metabolite formed by oxidation at the benzylic carbon (3.0% of total dose), and its hydrolytic N-dealkylation product (3.6% of total dose). The empirical formula is C20H18F2N3NaO5 and the molecular weight is 441.36 g per mol. Tivicay is used to treat HIV in adults and children 12 and over who weigh at least 66 pounds (30 kilograms). Pediatric Patients: The pharmacokinetics of dolutegravir were evaluated in the IMPAACT P1093 trial and in 2 weight-band-based pharmacokinetic substudies from the ODYSSEY trial. Tivicay may harm an unborn baby if you take the medicine at the time of conception or during the first 12 weeks of pregnancy. 3 Tivicay is never prescribed on its own. In vitro, dolutegravir was not a substrate of OATP1B1 or OATP1B3. simultaneous administration. Tivicay tablets are for use in adults and children who can swallow tablets. Tivicay pregnancy and breastfeeding warnings. Check to make sure you receive the correct form of Tivicay each time you or your childs prescription is filled to avoid using the wrong medicine. -Prophylaxis should be started as soon as possible, within 72 hours of exposure. Generic name: dolutegravir sodium Mean reduction from baseline in HIV-1 RNA at Day 8 (primary endpoint) was 1.4 log10 (95% CI: 1.3 log10, 1.5 log10). The safety analysis based on subjects (n = 75) who received the recommended dose (determined by weight and age) through Week 24 showed that 11% of subjects experienced drug-related clinical adverse reactions. Store TIVICAY 10-mg, 25-mg, and 50-mg tablets at room temperature between 68F to 77F (20C to 25C). The tablet film-coating contains hypromellose, polyethylene glycol, and titanium dioxide. Store at controlled room temperature of 25C (77F); excursions permitted to 15 to 30C (59 to 86F) (see USP). Stop taking this medicine and get emergency medical help if you have signs of an allergic reaction to Tivicay: fever, general ill feeling, trouble breathing, tiredness; joint or muscle pain, blisters or mouth sores, redness or swelling in your eyes; blistering or peeling skin; swelling of your face, lips, tongue, or throat. What are the ingredients in Tivicay and Tivicay PD? Erectile dysfunction (ED) is often a symptom . The rate of adverse events leading to discontinuation through Week 48 was 4% in subjects receiving Tivicay plus rilpivirine once daily and less than 1% in subjects who remained on their current antiretroviral regimen. Tivicay or Tivicay PD can cause serious side effects including: Stop taking Tivicay or Tivicay PD and get medical help right away if you develop a rash with any of the following signs or symptoms: Call your healthcare provider right away if you develop any of the following signs or symptoms of liver problems, Changes in your immune system (Immune Reconstitution Syndrome). There were 484 subjects included in the efficacy and safety analyses. In addition, a diminished virologic response of 40% (6 of 15) was observed when the substitution E157Q or K was present at baseline with other INSTI-resistance substitutions but without a Q148H or R substitution. Always give this medicine exactly as your healthcare provider tells you. Available for Android and iOS devices. Repeat if any medicine remains in the syringe to make sure the infant gets the full dose. INSTI = integrase strand transfer inhibitor. ---This drug should not be used in pregnant women early in pregnancy as the risk of an unborn infant developing a neural tube defect is during the first 28 days. Use alternative combinations that do not include metabolic inducers where possible for INSTI-experienced patients with certain INSTI-associated resistance substitutions or clinically suspected INSTI resistance.b. Descovy, Truvada, tenofovir, Atripla, Complera, Epzicom, Stribild. swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence. Dual-purpose vardenafil hydrochloride/dapoxetine hydrochloride orodispersible tablets: in vitro formulation/evaluation, stability study and in vivo comparative pharmacokinetic study in healthy human subjects Erectile dysfunction (ED) is the most important disorder after premature ejaculation for sexual activity in men. (dolutegravir) tablets, for oral use Initial U.S. Approval: 2013 ----- Dosage and Administration, Pediatric Patients (2.2) 06/2016 INDICATIONS AND USAGE TIVICAY is a human immunodeficiency virus type 1 (HIV-1) integrase strand Passage of mutant viruses containing both G140S and Q148H selected for L74M, E92Q, and N155H. Follow all directions on your prescription label and read all medication guides or instruction sheets. In a randomized, placebo-controlled, cross-over trial, 42 healthy subjects received single-dose oral administrations of placebo, dolutegravir 250-mg suspension (exposures approximately 3fold of the 50-mg once-daily dose at steady state), and moxifloxacin 400 mg (active control) in random sequence. Grades 2 to 4 ALT abnormalities in hepatitis B and/or C co-infected compared with HIV mono-infected subjects receiving Tivicay were observed in 18% vs. 3% with the 50-mg once-daily dose and 13% vs. 8% with the 50-mg twice-daily dose. Tivicay and Tivicay PD are contraindicated in patients: Hypersensitivity reactions have been reported and were characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury. It belongs to a group of medicines called phosphodiesterase 5 (PDE5) inhibitors. Dolutegravir plasma concentrations increased in a less than dose-proportional manner above 50 mg. Dolutegravir is a Pgp substrate in vitro. Clinical trials of Tivicay did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects. Seven cases reported with dolutegravir included 3 cases of myelomeningocele, 2 cases of encephalocele, and one case each of anencephaly and iniencephaly. The most common side effects of TIVICAY include: trouble sleeping. In the rat pre/postnatal development study, decreased body weight of the developing offspring was observed during lactation at a maternally toxic dose (approximately 27 times human exposure at the MRHD). Gastrointestinal Disorders: Abdominal pain, abdominal discomfort, flatulence, upper abdominal pain, vomiting. Treatment-Experienced, Integrase Strand Transfer Inhibitor-Experienced Subjects: In a multicenter, open-label, singlearm trial (ING112574, VIKING-3), 183 HIV1infected, antiretroviral treatment-experienced adults with virological failure and current or historical evidence of raltegravir and/or elvitegravir resistance received Tivicay 50 mg twice daily with the current failing background regimen for 7 days and with optimized background therapy from Day 8. During the initial phase of combination antiretroviral treatment, patients whose immune systems respond may develop an inflammatory response to indolent or residual opportunistic infections (such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia [PCP], or tuberculosis), which may necessitate further evaluation and treatment. Use ) cases reported with dolutegravir included 3 cases of encephalocele, and titanium dioxide the health of and. 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