Prescription Drug Information: Oseltamivir Phosphate (Page 7 of 8)

14.2 Prophylaxis of Influenza

Adult and Adolescent Subjects (13 years of age and older)

The efficacy of oseltamivir phosphate in preventing naturally occurring influenza illness has been demonstrated in three seasonal prophylaxis (community outbreak) clinical trials and one post-exposure prophylaxis trial in household contacts. The efficacy endpoint for all of these trials was the incidence of laboratory-confirmed clinical influenza defined as meeting all the following criteria (all signs and symptoms must have been recorded within 24 hours):

  • oral temperature greater than or equal to 99ºF (37.2ºC),
  • at least one respiratory symptom (cough, sore throat, nasal congestion),
  • at least one constitutional symptom (aches and pain, fatigue, headache, chills/sweats), and
  • either a positive virus isolation or a four-fold increase in virus antibody titers from baseline.

In a pooled analysis of two seasonal prophylaxis trials in healthy unvaccinated adults (aged 18 to 65 years), oseltamivir phosphate 75 mg once daily taken for 42 days during a community outbreak reduced the incidence of laboratory-confirmed clinical influenza from 5% (25/519) for the placebo group to 1% (6/520) for the oseltamivir phosphate group.

In the seasonal (community outbreak) prophylaxis trial in elderly residents of skilled nursing homes, about 80%, 43%, and 14% of the subjects were vaccinated, had cardiac disorders, and had chronic airway obstructive disorders, respectively. In this trial, subjects were randomized to oseltamivir phosphate 75 mg once daily or placebo taken orally for 42 days. The incidence of laboratory-confirmed clinical influenza was 4% (12/272) in the placebo-treated subjects compared to less than 1% (1/276) in the oseltamivir phosphate-treated subjects.

In the post-exposure prophylaxis trial in household contacts (aged 13 years or older) of an index influenza case, oseltamivir phosphate 75 mg once daily or placebo taken orally was administered within 48 hours of onset of symptoms in the index case and continued for 7 days (index cases did not receive oseltamivir phosphate treatment). The incidence of laboratory-confirmed clinical influenza was 12% (24/200) in the placebo-treated subjects compared to 1% (2/205) in the oseltamivir phosphate-treated subjects.

Pediatric Subjects (1 year to 12 years of age)

The efficacy of oseltamivir phosphate in preventing naturally occurring influenza illness was demonstrated in a randomized, open-label post-exposure prophylaxis trial in household contacts that included pediatric subjects aged 1 year to 12 years, both as index cases and as family contacts. All index cases in this trial received oseltamivir phosphate for oral suspension 30 to 60 mg taken orally once daily for 10 days. The efficacy parameter was the incidence of laboratory-confirmed clinical influenza in the household. Laboratory-confirmed clinical influenza was defined as meeting all of the following criteria:

  • oral temperature at least 100°F (37.8°C),
  • cough and/or coryza recorded within 48 hours, and
  • either a positive virus isolation or a four-fold or greater increase in virus antibody titers from baseline or at illness visits.

Among household contacts 1 year to 12 years of age not already shedding virus at baseline, the incidence of laboratory-confirmed clinical influenza was lower in the group who received oseltamivir phosphate prophylaxis [3% (3/95)] compared to the group who did not receive oseltamivir phosphate prophylaxis [17% (18/106)].

Immunocompromised Subjects

A double-blind, placebo-controlled trial was conducted for seasonal prophylaxis of influenza in 475 immunocompromised subjects (including 18 pediatric subjects 1 year to 12 years of age) who had received solid organ (n=388; liver, kidney, liver and kidney) or hematopoietic stem cell transplants (n=87). Median time since transplant for solid organ transplant recipients was 1,105 days for the placebo group and 1,379 days for the oseltamivir phosphate group. Median time since transplant for hematopoietic stem cell transplant recipients was 424 days for the placebo group and 367 days for the oseltamivir phosphate group. Approximately 40% of subjects received influenza vaccine prior to entering the study. The primary efficacy endpoint was the incidence of confirmed clinical influenza, defined as oral temperature higher than 99°F (37.2°C) plus cough and/or coryza, all recorded within 24 hours, plus either a positive virus culture or a four-fold increase in virus antibody titers from baseline. Subjects received treatment with oseltamivir phosphate 75 mg or placebo once daily by mouth for 12 weeks. The incidence of confirmed clinical influenza was 3% (7/238) in the placebo group compared with 2% (5/237) in the oseltamivir phosphate group; this difference was not statistically significant. A secondary analysis was performed using the same clinical symptoms and RT-PCR for laboratory confirmation of influenza infection. Among subjects who were not already shedding virus at baseline, the incidence of RT-PCR-confirmed clinical influenza infection was 3% (7/231) in the placebo group and <1% (1/232) in the oseltamivir phosphate group.

16 HOW SUPPLIED/STORAGE AND HANDLING

Oseltamivir Phosphate for Oral Suspension (Supplied as Powder)

Supplied as a white to off-white colored powder blend in a glass bottle. After constitution, the powder blend produces a white to off-white colored tutti-frutti-flavored oral suspension. After constitution with 55 mL of water, each bottle delivers a usable volume of 60 mL of oral suspension equivalent to 360 mg oseltamivir base (6 mg/mL) [see Dosage and Administration (2.5)] (NDC 42291-567-60).

Storage

Store dry powder at 20º to 25ºC (68º to 77ºF); excursions permitted between 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature].

Store constituted oral suspension under refrigeration for up to 17 days at 2º to 8ºC (36º to 46ºF). Do not freeze. Alternatively, store constituted oral suspension for up to 10 days at 20º to 25ºC (68º to 77ºF); excursions permitted between 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Serious Skin/Hypersensitivity Reactions

Advise patients and/or caregivers of the risk of severe allergic reactions (including anaphylaxis) or serious skin reactions. Instruct patients and/or caregiver to stop oseltamivir phosphate and seek immediate medical attention if an allergic-like reaction occurs or is suspected [see Warnings and Precautions (5.1)] .

Neuropsychiatric Events

Advise patients and/or caregivers of the risk of neuropsychiatric events in oseltamivir phosphate-treated patients with influenza and instruct patients to contact their physician if they experience signs of abnormal behavior while receiving oseltamivir phosphate [see Warnings and Precautions (5.2)] .

Important Dosing Information

Instruct patients to begin treatment with oseltamivir phosphate as soon as possible from the first appearance of flu symptoms, within 48 hours of onset of symptoms. Similarly, instruct patients to start taking oseltamivir phosphate for prevention as soon as possible after exposure [see Dosage and Administration (2)] . Instruct patients to take any missed doses as soon as they remember, except if it is near the next scheduled dose (within 2 hours), and then continue to take oseltamivir phosphate at the usual times.

Influenza Vaccines

Instruct patients that oseltamivir phosphate is not a substitute for receiving an annual flu vaccination. Patients should continue receiving an annual flu vaccination according to guidelines on immunization practices. Because of the potential for oseltamivir phosphate to inhibit replication of live attenuated influenza vaccine (LAIV) and possibly reduce efficacy of LAIV, avoid administration of LAIV within 2 weeks or 48 hours after oseltamivir phosphate administration, unless medically necessary [see Drug Interactions (7.1)] .

Fructose Intolerance

Inform patients with hereditary fructose intolerance that one dose of 75 mg oseltamivir phosphate for oral suspension (supplied as powder) delivers 2 grams of sorbitol. Inform patients with hereditary fructose intolerance that this is above the daily maximum limit of sorbitol and may cause dyspepsia and diarrhea [see Warnings and Precautions (5.4)] .

Manufactured for:

AvKARE, Inc.

Pulaski, TN 38478

Mfg. Rev. 04-2018-01

AV 12/18 (P)

PATIENT INFORMATION

Oseltamivir Phosphate (oh” sel tam’ i vir fos’ fate) for Oral Suspension

What is oseltamivir phosphate for oral suspension?

Oseltamivir phosphate for oral suspension is a prescription medicine used to:

  • treat the flu (influenza) in people 2 weeks of age and older who have had flu symptoms for no more than two days.
  • prevent the flu in people who are 1 year of age and older.

It is not known if oseltamivir phosphate for oral suspension is:

  • effective in people who start treatment after 2 days of developing flu symptoms.
  • effective for the treatment of the flu in people with long-time (chronic) heart problems or breathing problems.
  • effective for the treatment or prevention of flu in people who have weakened immune systems (immunocompromised).
  • safe and effective for the treatment of the flu in children less than 2 weeks of age.
  • safe and effective in the prevention of the flu in children less than 1 year of age.

Oseltamivir phosphate for oral suspension does not treat or prevent illness that is caused by infections other than the influenza virus.

Oseltamivir phosphate for oral suspension does not prevent bacterial infections that may happen with the flu.

Oseltamivir phosphate for oral suspension is not recommended for people with end-stage renal disease (ESRD) who are not receiving dialysis.

Oseltamivir phosphate for oral suspension does not take the place of receiving a flu vaccination. Talk to your healthcare provider about when you should receive an annual flu vaccination.

Who should not take oseltamivir phosphate for oral suspension?

Do not take oseltamivir phosphate for oral suspension if you are allergic to oseltamivir phosphate or any of the ingredients in oseltamivir phosphate for oral suspension. See the end of this leaflet for a complete list of ingredients in oseltamivir phosphate for oral suspension.

What should I tell my healthcare provider before taking oseltamivir phosphate for oral suspension?

Before you take oseltamivir phosphate for oral suspension, tell your healthcare provider if you:

  • have kidney problems
  • have a history of fructose (fruit sugar) intolerance. Oseltamivir phosphate for oral suspension contains sorbitol and may cause stomach upset and diarrhea in people who are fructose intolerant.
  • have any other medical conditions
  • are pregnant or plan to become pregnant. Available information indicate that oseltamivir phosphate for oral suspension does not increase the risk of birth defects.
  • are breastfeeding or plan to breastfeed. Oseltamivir phosphate can pass into breast milk in small amounts.

Tell your healthcare provider about all the medicines you take, including prescription or over-the-counter medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take oseltamivir phosphate for oral suspension?

  • Take oseltamivir phosphate for oral suspension exactly as your healthcare provider tells you to.
  • Take oseltamivir phosphate for oral suspension with food or without food. There is less chance of stomach upset if you take oseltamivir phosphate for oral suspension with food.
  • If you miss a dose of oseltamivir phosphate for oral suspension, take it as soon as you remember. If it is 2 hours or less before your next dose, do not take the missed dose. Take your next dose of oseltamivir phosphate for oral suspension at your scheduled time. Do not take 2 doses at the same time.
  • If oseltamivir phosphate for oral suspension is not available or you cannot swallow oseltamivir phosphate capsules, your healthcare provider or pharmacist may instruct you to open oseltamivir phosphate capsules and mix the capsules contents with sweetened liquids such as chocolate syrup (regular or sugar-free), corn syrup, caramel topping, or light brown sugar (dissolved in water).
  • If your healthcare provider or pharmacist has instructed you to take oseltamivir phosphate for oral suspension, read the detailed Instructions for Use at the end of this leaflet. Ask your pharmacist if you have any questions.

What are the possible side effects of oseltamivir phosphate for oral suspension?

Oseltamivir phosphate for oral suspension may cause serious side effects, including:

  • Serious skin and allergic reactions. Oseltamivir phosphate for oral suspension can cause serious skin and allergic reactions. Stop taking oseltamivir phosphate for oral suspension and get medical help right away if you get any of the following symptoms:
    • skin rash or hives

    • your skin blisters and peels

    • blisters or sores in your mouth

    • itching

    • swelling of your face, eyes, lips, tongue, or throat

    • trouble breathing

    • chest pain or tightness

  • Change in behavior. People, especially children, who have the flu, can develop nervous system problems and abnormal behavior that can lead to death. During treatment with oseltamivir phosphate for oral suspension, tell your healthcare provider right away if you or your child have confusion, speech problems, shaky movements, seizures, or start hearing voices or seeing things that are not really there (hallucinations).

The most common side effects of oseltamivir phosphate for oral suspension when used for treatment of the flu include nausea, vomiting, and headache.

The most common side effect of oseltamivir phosphate for oral suspension when used for prevention of the flu include nausea, vomiting, headache, and pain.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of oseltamivir phosphate for oral suspension.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store oseltamivir phosphate for oral suspension?

  • Store oseltamivir phosphate for oral suspension in the refrigerator for up to 17 days between 36ºF to 46ºF (2ºC to 8ºC).
  • Store oseltamivir phosphate for oral suspension for up to 10 days at room temperature between 68°F to 77°F (20°C to 25°C).
  • Safely throw away any unused oseltamivir phosphate for oral suspension that is out of date or no longer needed.

Keep oseltamivir phosphate for oral suspension and all medicines out of the reach of children.

General information about the safe and effective use of oseltamivir phosphate for oral suspension.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use oseltamivir phosphate for oral suspension for a condition for which it was not prescribed. Do not give oseltamivir phosphate for oral suspension to other people, even if they have the same symptoms you have. It may harm them. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about oseltamivir phosphate for oral suspension that is written for health professionals. For more information, go to www.amneal.com.

What are the ingredients in oseltamivir phosphate for oral suspension?

Active ingredient: oseltamivir phosphate, USP

Inactive ingredients:

Oseltamivir phosphate for oral suspension: monosodium citrate, saccharin sodium, sodium benzoate, sorbitol, titanium dioxide, tutti-frutti flavoring, and xanthan gum.

Manufactured for:

AvKARE, Inc.

Pulaski, TN 38478

Mfg. Rev. 04-2018-01

AV 12/18 (P)

This Patient Information has been approved by the U.S. Food and Drug Administration.

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