Lamihope

Lamihope 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.

Lamihope 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 Lamihope tablets:

Lamihope 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).

Lamihope 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. Lamihope will not keep you from spreading HIV to other people. People who receive Lamihope may continue to have other problems usually related to AIDS or HIV disease.

Lamihope is also used to treat chronic (long-term) hepatitis B virus (HBV) infection.

Lamihope 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, Lamihope is used in certain patients with the following medical condition:

• Human immunodeficiency virus (HIV) infection due to occupational exposure (possible prevention of)

Recommended Dosage For Adult Patients

The recommended dosage of Lamihope 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 Lamihope 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 Lamihope 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.

Lamihope 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 Lamihope scored tablets, pediatric patients should be assessed for the ability to swallow tablets. For patients unable to safely and reliably swallow Lamihope tablets, the oral solution formulation should be prescribed. The recommended oral dosage of Lamihope tablets for HIV-1-infected pediatric patients is presented in Table 1.

Table 1: Dosing Recommendations for Lamihope Scored (150-mg) Tablets in Pediatric Patients

Patients With Renal Impairment

Dosing of Lamihope is adjusted in accordance with renal function. Dosage adjustments are listed in Table 2.

Table 2: Adjustment of Dosage of Lamihope in Adults and Adolescents (Greater than or Equal to 25 kg) in Accordance with Creatinine Clearance

No additional dosing of Lamihope is required after routine (4-hour) hemodialysis or peritoneal dialysis.

Although there are insufficient data to recommend a specific dose adjustment of Lamihope 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

Lamihope Scored Tablets

Lamihope scored tablets contain 150 mg of Lamihope. The tablets are white, diamond-shaped, scored, film-coated tablets debossed with “GX CJ7” on both sides.

Lamihope Tablets

Lamihope tablets contain 300 mg of Lamihope. The tablets are gray, modified diamond-shaped, film-coated, and engraved with “GX EJ7” on one side and plain on the reverse side.

Lamihope

Oral Solution

Lamihope oral solution contains 10 mg of Lamihope per 1 mL. The solution is a clear, colorless to pale yellow, strawberry-banana flavored liquid.

Storage And Handling

Lamihope scored tablets contain 150 mg of Lamihope, 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.

Lamihope tablets contain 300 mg of Lamihope, 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 Lamihope tablets at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).

Lamihope oral solution is a clear, colorless to pale yellow, strawberry-banana-flavored liquid. Each mL of the solution contains 10 mg of Lamihope. 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

See also:
What is the most important information I should know about Lamihope?

You should not take Lamihope if you are allergic to it.

The Lamihope brand of Lamihope (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 Lamihope-HBV brand of Lamihope (for treating hepatitis B) should not be taken together with any other medication that contains Lamivudine, which includes Combivir, Lamihope, Epzicom, and Trizivir.

Before taking Lamihope, tell your doctor if you have kidney disease, liver disease, a history of pancreatitis, or if you have used a medicine similar to Lamihope 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 Lamihope. 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 Lamihope. Visit your doctor regularly.

Lamihope 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 Lamihope: 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).

Lamihope tablets and liquid contain a higher dose of Lamihope than Lamihope-HBV. Each time you get a refill of this medication, be sure you have received the correct brand to treat your condition.

Use Lamihope

Oral Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Lamihope

  Oral Solution. Talk to your pharmacist if you have questions about this information.

• Take Lamihope

  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 Lamihope

  Oral Solution even if you feel well. Do not miss any doses.

• Taking Lamihope

  Oral Solution at the same time each day will help you remember to take it.

• If you miss a dose of Lamihope

  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 Lamihope

Oral Solution.

Use: Labeled Indications

Chronic hepatitis B (Lamihope 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. Lamihope-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 (Lamihope): 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, Lamihope (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, Lamihope, 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.

See also:
What other drugs will affect Lamihope?

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.

Lamihope 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 Lamihope.

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 Lamihope.

Administration of trimethoprim/sulphamethoxazole 160 mg/800 mg increased Lamihope exposure by about 40%. Lamihope had no effect on the pharmacokinetics of trimethoprim or sulphamethoxazole. However, unless the patient has renal impairment, no dosage adjustment of Lamihope is necessary.

A modest increase in C_max (28%) was observed for zidovudine when administered with Lamihope, however overall exposure (AUC) was not significantly altered. Zidovudine had no effect on the pharmacokinetics of Lamihope.

Lamihope 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 Lamihope concurrently with commonly used immunosuppressant medicinal products (e.g. cyclosporin A). However, formal interaction studies have not been performed.

Emtricitabine: Due to similarities, Lamihope should not be administered concomitantly with other cytidine analogues, such as emtricitabine. Moreover, Lamihope should not be taken with any other medicinal products containing Lamihope.

Cladribine: In vitro Lamihope 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 Lamihope and cladribine. Therefore, the concomitant use of Lamihope with cladribine is not recommended.

See also:
What are the possible side effects of Lamihope?

Clinical Trial Data: In clinical studies of patients with chronic hepatitis B, Lamihope 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 Lamihope-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 Lamihope. 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 Lamihope 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 Lamihope- and placebo-treated patients. The relationship of these recurrent hepatitis events to Lamihope 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 Lamihope.

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 Lamihope has been clearly established. In patients with chronic hepatitis B, there was no observed difference in incidence of these events between placebo- and Lamihope-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 Lamihope.