NALFON (fenoprofen calcium)

There are 7 contraindications. Absolute contraindication.

Contraindication List
Aspirin exacerbated respiratory disease
Cerebrovascular accident
History of roux-en-Y gastric bypass
Post-operative from CABG surgery
Pregnancy
Renal papillary necrosis
Renal transplant

There are 17 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Acute myocardial infarction
Alcohol use disorder
Chronic heart failure
Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
Chronic kidney disease stage 5 (failure) GFr<15 ml/min
Drug-induced hepatitis
Gastrointestinal hemorrhage
Gastrointestinal perforation
Gastrointestinal ulcer
History of kidney donation
Increased risk of bleeding
Increased risk of bleeding due to coagulation disorder
Kidney disease with likely reduction in glomerular filtration rate (GFr)
Nephrectomy
Systemic mastocytosis
Thrombotic disorder
Tobacco smoker

There are 5 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Anemia
Disease of liver
Edema
Hearing loss
Hypertension

There are 65 severe adverse reactions.

More Frequent	Less Frequent
Abnormal hepatic function tests Body fluid retention Edema	Acute cognitive impairment Blurred vision Dyspnea Dysuria Skin rash Tinnitus Visual changes

Rare/Very Rare

Acute eruptions of skin Acute myocardial infarction Acute pancreatitis Agranulocytosis Allergic dermatitis Anaphylaxis Anemia Angioedema Aphthous stomatitis Aplastic anemia Bloody stools Bloody vomit Bronchospastic pulmonary disease Bruising Bullous dermatitis Cardiac arrhythmia Cerebrovascular accident Chest pain Cystitis Depression Diplopia DRESS syndrome Drug-induced hepatitis Ecchymosis Exfoliative dermatitis Fever Gastric ulcer Gastritis Gastrointestinal hemorrhage Gastrointestinal perforation Gastrointestinal ulcer Hematuria Hemolytic anemia Hepatic failure Hepatic necrosis Hepatitis Hyperkalemia Hypertension Interstitial nephritis Jaundice Kidney disease with reduction in glomerular filtration rate (GFr) Nephrotic syndrome Nephrotoxicity Pancytopenia Peptic ulcer Platelet aggregation inhibition Pruritus of skin Pulmonary edema Purpura Renal failure Seizure disorder Stevens-johnson syndrome Thrombocytopenic disorder Toxic epidermal necrolysis Urticaria

There are 24 less severe adverse reactions.

More Frequent	Less Frequent
Constipation Dizziness Drowsy Dyspepsia Headache disorder Nausea Nervousness	Abdominal pain with cramps Diarrhea Fatigue General weakness Hearing loss Hyperhidrosis Mouth irritation Palpitations Pharyngitis Tremor Vomiting

Rare/Very Rare
Anorexia Dysgeusia Flatulence Insomnia Tachycardia Xerostomia

Use of NSAIAs during pregnancy at about 30 weeks of gestation or later can cause premature closure of the fetal ductus arteriosus, and use at about 20 weeks of gestation or later has been associated with fetal renal dysfunction resulting in oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, use of NSAIAs should be avoided in pregnant women at about 30 weeks of gestation or later; if NSAIA therapy is necessary between about 20 and 30 weeks of gestation, the lowest effective dosage and shortest possible duration of treatment should be used. Monitoring of amniotic fluid volume via ultrasound examination should be considered if the duration of NSAIA treatment exceeds 48 hours; if oligohydramnios occurs, the drug should be discontinued and follow-up instituted according to clinical practice.

Pregnant women should be advised to avoid use of NSAIAs beginning at 20 weeks' gestation unless otherwise advised by a clinician; they should be informed that NSAIAs should be avoided beginning at 30 weeks' gestation because of the risk of premature closure of the fetal ductus arteriosus and that monitoring for oligohydramnios may be necessary if NSAIA therapy is required for longer than 48 hours' duration between about 20 and 30 weeks of gestation. Known effects of NSAIAs on the human fetus during the third trimester of pregnancy include prenatal constriction of the ductus arteriosus, tricuspid incompetence, and pulmonary hypertension; nonclosure of the ductus arteriosus during the postnatal period (which may be resistant to medical management); and myocardial degenerative changes, platelet dysfunction with resultant bleeding, intracranial bleeding, renal dysfunction or renal failure, renal injury or dysgenesis potentially resulting in prolonged or permanent renal failure, oligohydramnios, GI bleeding or perforation, and increased risk of necrotizing enterocolitis. Fetal renal dysfunction resulting in oligohydramnios and, in some cases, neonatal renal impairment has been observed, on average, following days to weeks of maternal NSAIA use, although oligohydramnios has been observed infrequently as early as 48 hours after initiation of NSAIA therapy.

Oligohydramnios is often, but not always, reversible (generally within 3-6 days) following discontinuance of NSAIA therapy. Complications of prolonged oligohydramnios may include limb contracture and delayed lung maturation. A limited number of case reports have described maternal NSAIA use and neonatal renal dysfunction, in some cases irreversible, without oligohydramnios.

Some cases of neonatal renal dysfunction have required treatment with invasive procedures such as exchange transfusion or dialysis. Deaths associated with neonatal renal failure have been reported. Methodologic limitations of these postmarketing studies and case reports include lack of a control group; limited information regarding dosage, duration, and timing of drug exposure; and concomitant use of other drugs.

These limitations preclude establishing a reliable estimate of the risk of adverse fetal and neonatal outcomes with maternal NSAIA use. Available data on neonatal outcomes generally involved preterm infants, and the extent to which certain reported risks can be generalized to full-term infants is uncertain. Animal data indicate that prostaglandins have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization.

In animal studies, inhibitors of prostaglandin synthesis, such as fenoprofen, were associated with increased pre- and post-implantation losses. Prostaglandins also have an important role in fetal kidney development. In animal studies, inhibitors of prostaglandin synthesis impaired kidney development at clinically relevant doses.

Reproduction studies in rats and rabbits receiving fenoprofen calcium dosages of 0.15 and 0.6 times, respectively, the maximum recommended human dosage of 3.2

g daily (based on body surface area comparisons) have not revealed evidence of developmental abnormalities. The effects of fenoprofen on labor and delivery are unknown. In studies in rats, drugs that inhibit prostaglandin synthesis, including NSAIAs, increased the incidence of dystocia, delayed parturition, and decreased pup survival.

Fenoprofen is distributed into milk. Because of the potential for serious adverse reactions from fenoprofen in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.

No enhanced Geriatric Use information available for this drug.