Emergency Compounding

Directions for the Emergency Compounding of an Oral Suspension from Tamiflu 75 – mg Capsules (Final Concentration 6 mg/mL)

The following directions are provided for use only during emergency situations. These directions are not intended to be used if the FDA-approved, commercially manufactured Tamiflu for Oral Suspension is readily available from wholesalers or the manufacturer. Find the same instructions in the Prescribing Information.

Compounding an oral suspension with this procedure will provide 1 patient with enough medication for a 5-day course of treatment or a 10-day course of prophylaxis.

Commercially manufactured Tamiflu for oral suspension (6 mg/mL) is the preferred product for pediatric and adult patients who have difficulty swallowing capsules or where lower doses are needed. In the event that Tamiflu for oral suspension is not available, the pharmacist may compound a suspension (6 mg/mL) from Tamiflu capsules 75 mg using one of these vehicles: Cherry Syrup (Humco®), Ora-Sweet® SF (sugar-free) (Paddock Laboratories), or simple syrup. Other vehicles have not been studied.

This compounded suspension should not be used for convenience or when the FDA-approved Tamiflu for oral suspension is commercially available.

Compounding instructions

First, determine the dose of Tamiflu for the patients, then determine total volume of an oral suspension needed to be compounded based on the table below.

Volume of an Oral Suspension (6 mg/mL) Needed to Be Compounded Based Upon the Patient's Tamiflu Dose

If the Tamiflu dose is between the doses listed, the total volume of oral suspension to compound should default to the next greater dose listed.

Second, determine the number of capsules and the amount of water and vehicle (Cherry Syrup, Ora-Sweet SF, or simple syrup) that are needed to prepare the total volume of compounded oral suspension (6 mg/mL) by using the table below.

Number of Tamiflu 75 mg Capsules and Amount of Vehicle (Cherry Syrup, Ora Sweet® SF, or Simple Syrup) Needed to Prepare the Total Volume of a Compounded Oral Suspension (6 mg/mL)

Includes overage to ensure all doses can be delivered.

Third, follow the procedure below for compounding the oral suspension (6 mg/mL) from 75-mg Tamiflu capsules:

  1. Place the specified amount of water into a polyethylene terephthalate (PET) or glass bottle (see above).
  2. Carefully separate the capsule body and cap, and pour the contents of the required number of 75 mg Tamiflu capsules into the PET or glass bottle. Weighing paper may also be used to hold capsule contents for transfer into bottle.
  3. Gently swirl the suspension to ensure adequate wetting of the Tamiflu powder for at least 2 minutes.
  4. Slowly add the specified amount of vehicle to the bottle.
  5. Close the bottle using a child-resistant cap and shake well for 30 seconds to completely dissolve the active drug and to ensure homogeneous distribution of the dissolved drug in the resulting suspension. (Note: The active drug, oseltamivir phosphate, readily dissolves in the specified vehicles. The suspension is caused by inert ingredients of Tamiflu capsules that are insoluble in these vehicles.)
  6. Put an ancillary label on the bottle indicating “Shake Well Before Use.”
  7. Instruct the parent or caregiver that any unused suspension remaining in the bottle following completion of therapy must be discarded by either affixing an ancillary label to the bottle, or adding a statement to the pharmacy label instructions.
  8. Place an appropriate expiration date on the label according to storage conditions below.
  9. Storage of the emergency compounded suspension

  • Refrigeration: stable for 5 weeks (35 days) when stored in a refrigerator at 2° to 8°C (36° to 46°F).
  • Room temperature: stable for 5 days when stored at room temperature, 25°C (77°F).

Note: The storage conditions are based on stability studies of compounded oral suspensions, using the aforementioned vehicles, which were placed in glass and polyethylene terephthalate (PET) bottles. Stability studies have not been conducted with other vehicles or bottle types.

Place a pharmacy label on the bottle that includes the patient’s name, dosing instructions, and drug name and any other required information to be in compliance with all state and federal pharmacy regulations.

Please see the Tamiflu full Prescribing Information for complete safety information.

Indications

Tamiflu is indicated for the treatment of acute, uncomplicated illness due to influenza infection in patients 2 weeks of age and older who have been symptomatic for no more than 2 days. Tamiflu is also indicated for the prophylaxis of influenza in patients 1 year and older

  • Efficacy of Tamiflu in patients who begin treatment after 48 hours of symptoms has not been established
  • Tamiflu is not a substitute for early and annual influenza vaccination
  • There is no evidence for efficacy of Tamiflu in any illness caused by agents other than influenza viruses types A and B
  • Influenza viruses change over time. Emergence of resistance mutations could decrease drug effectiveness. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use Tamiflu

Important Safety Information

Serious Skin/Hypersensitivity Reactions

  • Tamiflu is contraindicated in patients who have had severe allergic reactions such as anaphylaxis or serious skin reactions such as toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme to any component of Tamiflu
  • In postmarketing experience, cases of anaphylaxis and serious skin reactions, including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme, have been reported with Tamiflu. Tamiflu should be stopped and appropriate treatment instituted if an allergic-like reaction occurs or is suspected

Neuropsychiatric Events

  • Influenza can be associated with a variety of neurologic and behavioral symptoms, which can include events such as hallucinations, delirium and abnormal behavior, in some cases resulting in fatal outcomes. These events may occur in the setting of encephalitis or encephalopathy but can occur without obvious severe disease
  • Closely monitor patients with influenza for signs of abnormal behavior. If neuropsychiatric symptoms occur, evaluate the risks and benefits of continuing treatment for each patient

Bacterial Infections

  • Serious bacterial infections may begin with influenza-like symptoms or may coexist with or occur as complications during the course of influenza. Tamiflu has not been shown to prevent such complications

Limitations of Populations Studied

  • Efficacy of Tamiflu in the treatment of influenza in patients with chronic cardiac disease and/or respiratory disease has not been established. No information is available regarding treatment of influenza in patients with any medical condition sufficiently severe or unstable to be considered at imminent risk of requiring hospitalization
  • Efficacy of Tamiflu for treatment or prophylaxis of influenza has not been established in immunocompromised patients

Concurrent Use with Live Attenuated Influenza Vaccine

  • The concurrent use of Tamiflu with live attenuated influenza vaccine (LAIV) intranasal has not been evaluated. However, because of the potential for interference between these products, LAIV should not be administered within 2 weeks before or 48 hours after administration of Tamiflu, unless medically indicated

Most Common Adverse Reactions

  • Adverse events that occurred more frequently in patients treated with Tamiflu than in patients taking placebo (frequency ≥ 2%) across clinical trials were nausea, vomiting, abdominal pain, ear disorder, and diarrhea
  • The safety profile observed in pediatric patients 2 weeks to less than 1 year of age was consistent with the established safety profile of subjects aged 1 year and above, with vomiting, diarrhea and diaper rash being the most frequently reported adverse reactions

For additional important safety information, please see Tamiflu full prescribing information at www.tamiflu.com.

You are encouraged to report side effects to Genentech by calling 1-888-835-2555 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

Indications and Important Safety Information

Indications

Tamiflu is indicated for the treatment of acute, uncomplicated illness due to influenza infection in patients 2 weeks of age and older who have been symptomatic for no more than 2 days. Tamiflu is also indicated for the prophylaxis of influenza in patients 1 year and older

  • Efficacy of Tamiflu in patients who begin treatment after 48 hours of symptoms has not been established
  • Tamiflu is not a substitute for early and annual influenza vaccination
  • There is no evidence for efficacy of Tamiflu in any illness caused by agents other than influenza viruses types A and B
  • Influenza viruses change over time. Emergence of resistance mutations could decrease drug effectiveness. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use Tamiflu

Important Safety Information

Serious Skin/Hypersensitivity Reactions

  • Tamiflu is contraindicated in patients who have had severe allergic reactions such as anaphylaxis or serious skin reactions such as toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme to any component of Tamiflu
  • In postmarketing experience, cases of anaphylaxis and serious skin reactions, including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme, have been reported with Tamiflu. Tamiflu should be stopped and appropriate treatment instituted if an allergic-like reaction occurs or is suspected

Neuropsychiatric Events

  • Influenza can be associated with a variety of neurologic and behavioral symptoms, which can include events such as hallucinations, delirium and abnormal behavior, in some cases resulting in fatal outcomes. These events may occur in the setting of encephalitis or encephalopathy but can occur without obvious severe disease
  • Closely monitor patients with influenza for signs of abnormal behavior. If neuropsychiatric symptoms occur, evaluate the risks and benefits of continuing treatment for each patient

Bacterial Infections

  • Serious bacterial infections may begin with influenza-like symptoms or may coexist with or occur as complications during the course of influenza. Tamiflu has not been shown to prevent such complications

Limitations of Populations Studied

  • Efficacy of Tamiflu in the treatment of influenza in patients with chronic cardiac disease and/or respiratory disease has not been established. No information is available regarding treatment of influenza in patients with any medical condition sufficiently severe or unstable to be considered at imminent risk of requiring hospitalization
  • Efficacy of Tamiflu for treatment or prophylaxis of influenza has not been established in immunocompromised patients

Concurrent Use with Live Attenuated Influenza Vaccine

  • The concurrent use of Tamiflu with live attenuated influenza vaccine (LAIV) intranasal has not been evaluated. However, because of the potential for interference between these products, LAIV should not be administered within 2 weeks before or 48 hours after administration of Tamiflu, unless medically indicated

Most Common Adverse Reactions

  • Adverse events that occurred more frequently in patients treated with Tamiflu than in patients taking placebo (frequency ≥ 2%) across clinical trials were nausea, vomiting, abdominal pain, ear disorder, and diarrhea
  • The safety profile observed in pediatric patients 2 weeks to less than 1 year of age was consistent with the established safety profile of subjects aged 1 year and above, with vomiting, diarrhea and diaper rash being the most frequently reported adverse reactions

For additional important safety information, please see Tamiflu full prescribing information at www.tamiflu.com.

You are encouraged to report side effects to Genentech by calling 1-888-835-2555 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

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