Zetlam is used in combination with other medicines for the treatment of the infection caused by the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS).
Zetlam will not cure or prevent HIV infection or AIDS. It helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay the development of serious health problems usually related to AIDS or HIV disease from occurring. Zetlam will not keep you from spreading HIV to other people. People who receive Zetlam may continue to have other problems usually related to AIDS or HIV disease.
Zetlam is also used to treat chronic (long-term) hepatitis B virus (HBV) infection.
Zetlam is available only with your doctor's prescription.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, Zetlam is used in certain patients with the following medical condition:
Human immunodeficiency virus (HIV) infection due to occupational exposure (possible prevention of)
Zetlam indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Zetlam tablets are indicated for the treatment of chronic hepatitis B virus (HBV) infection associated with evidence of hepatitis B viral replication and active liver inflammation.
The following points should be considered when initiating therapy with Zetlam tablets:
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Due to high rates of resistance development in treated patients, initiation of treatment with Zetlam tablets should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate.
•
Zetlam tablets have not been evaluated in patients co-infected with HIV, hepatitis C virus (HCV), or hepatitis delta virus.
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Zetlam tablets have not been evaluated in liver transplant recipients or in patients with chronic hepatitis B virus infection with decompensated liver disease.
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Zetlam tablets have not been evaluated in pediatric patients younger than 2 years of age with chronic HBV infection.
How should I use Zetlam?
Use Zetlam
Oral Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
An extra patient leaflet is available with Zetlam
Oral Solution. Talk to your pharmacist if you have questions about this information.
Take Zetlam
Oral Solution by mouth with or without food.
Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
Continue to take Zetlam
Oral Solution even if you feel well. Do not miss any doses.
Taking Zetlam
Oral Solution at the same time each day will help you remember to take it.
If you miss a dose of Zetlam
Oral Solution, take it as soon as possible. If it is within 2 hours of your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Zetlam
Oral Solution.
Uses of Zetlam in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Use: Labeled Indications
Chronic hepatitis B (Zetlam HBV): Treatment of chronic hepatitis B associated with evidence of hepatitis B viral replication and active liver inflammation
Limitations of use: Use only when an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate. Zetlam-HBV has not been evaluated in patients coinfected with HIV, hepatitis C virus, or hepatitis delta virus; with decompensated liver disease; or in liver transplant recipients.
HIV-1 infection, treatment (Zetlam): Treatment of HIV-1 in combination with other antiretroviral agents
Off Label Uses
HIV-1 nonoccupational postexposure prophylaxis
Based on the Centers for Disease Control and Prevention, US Department of Health and Human Services updated guidelines for antiretroviral postexposure prophylaxis after sexual, injection drug use, or other nonoccupational exposure to HIV, Zetlam (in conjunction with other antiretrovirals) is an effective and recommended treatment option for postexposure prophylaxis of HIV-1 infection following nonoccupational exposure (nPEP) in individuals exposed to blood, genital secretions, or other potentially infectious body fluids that may contain HIV when that exposure represents a substantial risk for HIV transmission.
Prevention of perinatal HIV transmission
Based on the Health and Human Services (HHS) Perinatal HIV Guidelines, Zetlam, in combination with zidovudine and nevirapine, is a recommended regimen for empiric therapy to reduce the risk of perinatal transmission of HIV in HIV-exposed infants at higher risk of HIV-acquisition, including those born to HIV-infected women who did not receive antepartum or intrapartum antiretroviral drugs (ARV), who received only intrapartum ARV drugs, or who received antepartum and intrapartum ARV drugs but had a detectable viral load near delivery (particularly if delivery was vaginal), or mothers with acute HIV infection during pregnancy or breastfeeding. Empiric therapy with this combination provides prophylaxis against HIV acquisition and provides early treatment if HIV infection is later confirmed.
Zetlam description
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Zetlam also contains the following excipients: Tablet Core: Microcrystalline cellulose, sodium starch glycollate and magnesium stearate. Tablet Film-Coat: Hypromellose, titanium dioxide, macrogol 400, polysorbate 80 and synthetic yellow and red iron oxides.
Zetlam dosage
Recommended Dosage For Adult Patients
The recommended dosage of Zetlam in HIV-1-infected adults is 300 mg daily, administered as either 150 mg taken orally twice daily or 300 mg taken orally once daily with or without food. If Zetlam is administered to a patient infected with HIV-1 and HBV, the dosage indicated for HIV-1 therapy should be used as part of an appropriate combination regimen.
Recommended Dosage For Pediatric Patients
The recommended dosage of Zetlam oral solution in HIV-1-infected pediatric patients aged 3 months and older is 4 mg per kg taken orally twice daily or 8 mg per kg taken orally once daily (up to a maximum of 300 mg daily), administered in combination with other antiretroviral agents. Consider HIV-1 viral load and CD4+ cell count/percentage when selecting the dosing interval for patients initiating treatment with oral solution.
Zetlam scored tablet is the preferred formulation for HIV-1-infected pediatric patients who weigh at least 14 kg and for whom a solid dosage form is appropriate. Before prescribing Zetlam scored tablets, pediatric patients should be assessed for the ability to swallow tablets. For patients unable to safely and reliably swallow Zetlam tablets, the oral solution formulation should be prescribed. The recommended oral dosage of Zetlam tablets for HIV-1-infected pediatric patients is presented in Table 1.
Table 1: Dosing Recommendations for Zetlam Scored (150-mg) Tablets in Pediatric Patients
Weight (kg)
Once-Daily Dosing Regimen Patients may alternatively take one 300-mg tablet, which is not scored.
Patients With Renal Impairment
Dosing of Zetlam is adjusted in accordance with renal function. Dosage adjustments are listed in Table 2.
Table 2: Adjustment of Dosage of Zetlam in Adults and Adolescents (Greater than or Equal to 25 kg) in Accordance with Creatinine Clearance
Creatinine Clearance (mL/min)
Recommended Dosage of Zetlam
≥50
150 mg twice daily or 300 mg once daily
30-49
150 mg once daily
15-29
150 mg first dose, then 100 mg once daily
5-14
150 mg first dose, then 50 mg once daily
< 5
50 mg first dose, then 25 mg once daily
No additional dosing of Zetlam is required after routine (4-hour) hemodialysis or peritoneal dialysis.
Although there are insufficient data to recommend a specific dose adjustment of Zetlam in pediatric patients with renal impairment, a reduction in the dose and/or an increase in the dosing interval should be considered.
How supplied
Dosage Forms And Strengths
Zetlam Scored Tablets
Zetlam scored tablets contain 150 mg of Zetlam. The tablets are white, diamond-shaped, scored, film-coated tablets debossed with “GX CJ7” on both sides.
Zetlam Tablets
Zetlam tablets contain 300 mg of Zetlam. The tablets are gray, modified diamond-shaped, film-coated, and engraved with “GX EJ7” on one side and plain on the reverse side.
Zetlam
Oral Solution
Zetlam oral solution contains 10 mg of Zetlam per 1 mL. The solution is a clear, colorless to pale yellow, strawberry-banana flavored liquid.
Storage And Handling
Zetlam scored tablets contain 150 mg of Zetlam, are white, diamond-shaped, film-coated, and debossed with “GX CJ7” on both sides. Packaged as follows:
Bottle of 60 tablets (NDC 49702-203-18) with child-resistant closure.
Zetlam tablets contain 300 mg of Zetlam, are gray, modified diamond-shaped, film-coated, and engraved with “GX EJ7” on one side and plain on the reverse side. Packaged as follows:
Bottle of 30 tablets (NDC 49702-204-13) with child-resistant closure.
Recommended Storage
Store Zetlam tablets at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).
Zetlam oral solution is a clear, colorless to pale yellow, strawberry-banana-flavored liquid. Each mL of the solution contains 10 mg of Zetlam. Packaged as follows:
Plastic bottle of 240 mL (NDC 49702-205-48) with child-resistant closure. This product does not require reconstitution.
Store in tightly closed bottles at 25°C (77°F).
Manufactured for: ViiV Healthcare, Research Triangle Park, NC 27709 by: GlaxoSmithKline, Research Triangle Park, NC 27709. Manufactured under agreement from Shire Pharmaceuticals Group plc, Basingstoke, UK. Revised: July 2016
Interaction studies have only been performed in adults.
The likelihood of metabolic interactions is low due to limited metabolism and plasma protein binding and almost complete renal elimination of unchanged substance.
Zetlam is predominantly eliminated by active organic cationic secretion. The possibility of interactions with other medicinal products administered concurrently should be considered, particularly when their main route of elimination is active renal secretion via the organic cationic transport system e.g. trimethoprim. Other medicinal products (e.g. ranitidine, cimetidine) are eliminated only in part by this mechanism and were shown not to interact with Zetlam.
Substances shown to be predominately excreted either via the active organic anionic pathway, or by glomerular filtration are unlikely to yield clinically significant interactions with Zetlam.
Administration of trimethoprim/sulphamethoxazole 160 mg/800 mg increased Zetlam exposure by about 40%. Zetlam had no effect on the pharmacokinetics of trimethoprim or sulphamethoxazole. However, unless the patient has renal impairment, no dosage adjustment of Zetlam is necessary.
A modest increase in Cmax (28%) was observed for zidovudine when administered with Zetlam, however overall exposure (AUC) was not significantly altered. Zidovudine had no effect on the pharmacokinetics of Zetlam.
Zetlam has no pharmacokinetic interaction with alpha-interferon when the two medicinal products are concurrently administered. There were no observed clinically significant adverse interactions in patients taking Zetlam concurrently with commonly used immunosuppressant medicinal products (e.g. cyclosporin A). However, formal interaction studies have not been performed.
Emtricitabine: Due to similarities, Zetlam should not be administered concomitantly with other cytidine analogues, such as emtricitabine. Moreover, Zetlam should not be taken with any other medicinal products containing Zetlam.
Cladribine: In vitro Zetlam inhibits the intracellular phosphorylation of cladribine leading to a potential risk of cladribine loss of efficacy in case of combination in the clinical setting. Some clinical findings also support a possible interaction between Zetlam and cladribine. Therefore, the concomitant use of Zetlam with cladribine is not recommended.
Clinical Trial Data: In clinical studies of patients with chronic hepatitis B, Zetlam was well tolerated. The incidence of adverse events and laboratory abnormalities [with the exception of elevations of ALT and creatinine phosphokinase (CPK), see table] were similar between placebo and Zetlam-treated patients. The most common adverse events reported were malaise and fatigue, respiratory tract infections, headache, abdominal discomfort and pain, nausea, vomiting and diarrhoea.
Adverse reactions are listed as follows by system organ class and frequency. Frequency categories are only assigned to those adverse reactions considered to be at least possibly causally related to Zetlam. Frequencies are defined as: Very Common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1,000) and very rare (<1/10,000).
The frequency categories assigned to the following adverse reactions are estimates: For most events, suitable data for calculating incidence are not available. Very common and common adverse drug reaction frequency categories were determined from clinical trial data and the background incidence in placebo groups was not taken into account. Adverse drug reactions identified through post-marketing surveillance were categorized as rare or very rare.
Hepatobiliary Disorders: Very Common: Elevations of ALT.
Elevations in ALT were more common in posttreatment patients treated with Zetlam than placebo. In controlled trials in patients with compensated liver disease, however, there was no appreciable difference posttreatment in clinically severe ALT elevations associated with bilirubin elevations and/or signs of hepatic insufficiency, between Zetlam- and placebo-treated patients. The relationship of these recurrent hepatitis events to Zetlam treatment or to the previous underlying disease is uncertain.
Musculoskeletal and Connective Tissue Disorders: Common: Elevations of CPK.
Post-Marketing Data: In addition to adverse events reported from clinical trials, the following events have been identified during post-approval use of Zetlam.
Blood and Lymphatic System Disorders: Very Rare: Thrombocytopenia.
Musculoskeletal and Connective Tissue Disorders: Common: Muscle disorders, including myalgia and cramps. Very Rare: Rhabdomyolysis.
In patients with HIV infection, cases of pancreatitis and peripheral neuropathy (or paresthesia) have been reported, although no relationship to treatment with Zetlam has been clearly established. In patients with chronic hepatitis B, there was no observed difference in incidence of these events between placebo- and Zetlam-treated patients.
Cases of lactic acidosis, usually associated with severe hepatomegaly and hepatic steatosis, have been reported with the use of combination nucleoside analogue therapy in patients with HIV. There have been occasional reports of these adverse events in hepatitis B patients with decompensated liver disease, however, there is no evidence that these events were related to treatment with Zetlam.
You should not take Zetlam if you are allergic to it.
The Zetlam brand of Zetlam (for treating HIV) should not be taken together with any HIV combination medicine that contains Lamivudine or emtricitabine. This includes Atripla, Combivir, Complera, Emtriva, Epzicom, Trizivir, and Truvada.
The Zetlam-HBV brand of Zetlam (for treating hepatitis B) should not be taken together with any other medication that contains Lamivudine, which includes Combivir, Zetlam, Epzicom, and Trizivir.
Before taking Zetlam, tell your doctor if you have kidney disease, liver disease, a history of pancreatitis, or if you have used a medicine similar to Zetlam in the past, such as abacavir (Ziagen), didanosine (Videx), emtricitabine (Atripla, Complera, Emtriva, Truvada), stavudine (Zerit), tenofovir (Viread), zalcitabine (Hivid), or zidovudine (Retrovir).
Some people develop lactic acidosis while taking Zetlam. Early symptoms may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.
If you have hepatitis B you may develop liver symptoms after you stop taking this medication, even months after stopping. Your doctor may want to check your liver function for several months after you stop using Zetlam. Visit your doctor regularly.
Zetlam can also cause severe or life-threatening effects on your liver or pancreas. Call your doctor at once if you have any of these symptoms while taking Zetlam: severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).
Zetlam tablets and liquid contain a higher dose of Zetlam than Zetlam-HBV. Each time you get a refill of this medication, be sure you have received the correct brand to treat your condition.
DailyMed. "LAMIVUDINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
The results of a survey conducted on ndrugs.com for Zetlam are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Zetlam. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
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