TAMIFLU (oseltamivir phosphate)

There are 0 contraindications.

There are 4 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Chronic kidney disease stage 3A (moderate) GFR 45-59 ml/min
Chronic kidney disease stage 3B (moderate) GFR 30-44 ml/min
Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
Chronic kidney disease stage 5 (failure) GFr<15 ml/min

There are 4 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Acute cognitive impairment
Delirium
Kidney disease with likely reduction in glomerular filtration rate (GFr)
Suicidal ideation

There are 19 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Abnormal hepatic function tests Accidental injury Acute cognitive impairment Anaphylaxis Behavioral disorders Cardiac arrhythmia Delirium Erythema multiforme Facial edema Gastrointestinal hemorrhage Hallucinations Hemorrhagic colitis Hepatitis Hypothermia Seizure disorder Stevens-johnson syndrome Tongue swelling Toxic epidermal necrolysis Urticaria

There are 13 less severe adverse reactions.

More Frequent	Less Frequent
Headache disorder Nausea Vomiting	Diarrhea

Rare/Very Rare
Agitation Allergic dermatitis Delusional disorder Eczema Nightmares Pain Skin inflammation Skin rash Symptoms of anxiety

There are no adequate and well-controlled studies using oseltamivir in pregnant women to inform a drug-associated risk of adverse developmental outcomes. Available published epidemiological data suggest that oseltamivir administered during any trimester of pregnancy is not associated with an increased risk of birth defects; however, these studies had various limitations (e.g., small sample sizes, use of different comparison groups, lack of dosage information) which preclude a definitive assessment of the risk. Although data are insufficient to make a definitive assessment of the risk, prospective and retrospective observational studies that included approximately 5000 women exposed to oseltamivir during pregnancy (including approximately 1000 women exposed during the first trimester) suggest that the observed rate of congenital malformations following oseltamivir exposures during any trimester was not greater than that reported in the general population.

In animal reproduction studies, no adverse embryofetal effects were observed in pregnant rats and rabbits treated with oral oseltamivir at dosages resulting in clinically relevant exposures. There was a dose-dependent increase in the incidence rates of a variety of minor skeletal abnormalities and variants in offspring of rats and rabbits exposed to maternally toxic dosages (approximately 190 and at least 8 times usual human exposure, respectively). No adverse maternal or embryofetal effects were observed in rats exposed to maternally toxic dosages (approximately 44 times usual human exposure).

Pregnant women are at increased risk for severe complications from influenza, which may lead to adverse pregnancy and/or fetal outcomes including maternal death, still births, birth defects, preterm delivery, low birthweight, and small size for gestational age. Oseltamivir is the preferred antiviral for the treatment of suspected or confirmed influenza or prevention of influenza in women who are pregnant or up to 2 weeks postpartum.

Limited data indicate that oseltamivir and its active metabolite, oseltamivir carboxylate, are distributed into human milk in low concentrations that are considered unlikely to cause toxicity in nursing infants. The benefits of breast-feeding and the importance of oseltamivir to the woman should be considered along with potential adverse effects on the breast-fed child from the drug or from the underlying maternal condition.

No enhanced Geriatric Use information available for this drug.