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Generic tiopronin delayed-release tablets

Cycle Vita

Generic tiopronin delayed-release tablets are indicated in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 9 years of age and older with severe homozygous cystinuria, who are not responsive to these measures alone.1 Generic tiopronin delayed-release tablets must be taken without food and are available in 100 mg and 300 mg doses.1

For more information please visit www.cyclevita.life

Important Safety Information

INDICATIONS
Tiopronin delayed-release tablets are a reducing and complexing thiol indicated, in combination with high fluid intake, alkali, and diet modification, for prevention of cystine stone formation in adult and pediatric patients 9 years of age and older with severe homozygous cystinuria who are not responsive to these measures alone.

WARNINGS AND PRECAUTIONS
Proteinuria, including nephrotic syndrome, and membranous nephropathy, have been reported with tiopronin use. Pediatric patients receiving greater than 50 mg/kg of tiopronin per day may be at increased risk for proteinuria.
Hypersensitivity reactions (drug fever, rash, fever, arthralgia and lymphadenopathy) have been reported.

MOST COMMON ADVERSE REACTIONS
Most common adverse reactions (≥10%) are nausea, diarrhea or soft stools, oral ulcers, rash, fatigue, fever, arthralgia, proteinuria, and emesis.

DRUG INTERACTIONS
Alcohol: Tiopronin is released faster from tiopronin delayed-release tablets in the presence of alcohol and the risk for adverse events associated with tiopronin delayed-release tablets when taken with alcohol is unknown. Avoid alcohol consumption 2 hours before and 3 hours after taking tiopronin delayed-release tablets.

USE IN SPECIFIC POPULATIONS:
Pregnancy: Available published case report data with tiopronin have not identified a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. Renal stones in pregnancy may result in adverse pregnancy outcomes. Tell your healthcare provider immediately if you become pregnant or planning to become pregnant.

Lactation: There are no data on the presence of tiopronin in either human or animal milk or on the effects of the breastfed child. A published study suggests that tiopronin may suppress milk production. Because of the potential for serious adverse reactions, including nephrotic syndrome, advise patients that breastfeeding is not recommended during treatment with tiopronin delayed-release tablets. Tell your healthcare provider immediately if you plan on breast feeding.

Pediatric Use: Tiopronin delayed-release tablets are indicated in pediatric patients 9 years of age and older with severe homozygous cystinuria, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation who are not responsive to these measures alone.

Tiopronin delayed-release tablets are not approved for use in pediatric patients weighing less than 20 kg or in pediatric patients unable to swallow tablets.

Geriatric Use: This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

For more detailed information, please refer to the full Prescribing Information at https://www.tiopronin.us/pi

If you get any side effects, talk to your healthcare provider. This includes possible side effects not listed in this material. You may also report side effects directly by calling Torrent Pharma Inc. at: 1-800-912-9561 or FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch.

This material is for education purposes only. It is not intended to be, and should not be used as, a substitute for medical advice.

References

  1. Generic tiopronin delayed-release tablets. Prescribing Information. Torrent Pharma Inc.
Read the full tiopronin PI

NITYR® (nitisinone) Tablets / NITISINONE TABLETS

Nityr Logo

NITYR® (nitisinone) Tablets are a competitive inhibitor of 4-hydroxyphenyl-pyruvate dioxygenase indicated for the treatment of adult and pediatric patients with Hereditary Tyrosinemia Type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.

NITYR® is an alternative option to treat patients living with HT-1. HT-1 is an ultra-rare genetic metabolic disease that can cause hepatic, renal and neurological complications. In most cases, if left untreated, the disease is fatal.

NITYR® (nitisinone) Tablets are approved and being prescribed in many countries* across the world

Further detail is available at nityr.com for medical professionals and HT-1 patients in the US.

Important Safety Information

Do not prescribe NITYR to patients allergic to nitisinone or any other ingredients.

Warnings and Precautions:

Ocular Symptoms, Development Delay, and Hyperkeratotic Plaques Due to Elevated Plasma Tyrosine Levels:

Inadequate restriction of tyrosine and phenylalanine intake can lead to elevations in plasma tyrosine and levels above 500 micromol/L may lead to ocular signs and symptoms including corneal ulcers, corneal opacities, keratitis, conjunctivitis, eye pain, and photophobia; intellectual disability and developmental delay; or painful hyperkeratotic plaques on the soles and palms.

• Do not adjust the NITYR dosage in order to lower the plasma tyrosine concentration.
• Obtain slit-lamp examination prior to treatment and regularly thereafter. Reexamine patients if symptoms develop or tyrosine levels are > 500 micromol/L. Assess plasma tyrosine levels in patients with an abrupt change in neurologic status.
• Perform a clinical laboratory assessment, including plasma tyrosine levels, in patients with an abrupt change in neurologic status.

Leukopenia and Severe Thrombocytopenia
Monitor platelet and white blood cell counts.

Adverse Reactions:
The most common adverse reactions (≥1%) reported in patients with HT-1 taking nitisinone in the clinical trials are elevated tyrosine levels, thrombocytopenia, leukopenia, conjunctivitis, corneal opacity, keratitis, photophobia, eye pain, blepharitis, cataracts, granulocytopenia, epistaxis, pruritus, exfoliative dermatitis, dry skin, maculopapular rash, and alopecia.

Adverse reactions reported in less than 1% of the patients, included death, seizure, brain tumor, encephalopathy, hyperkinesia, cyanosis, abdominal pain, diarrhea, enanthema, gastrointestinal hemorrhage, melena, elevated hepatic enzymes, l

iver enlargement, hypoglycemia, septicemia, and bronchitis.

Drug Interactions:
• Nitisinone is a moderate CYP2C9 inhibitor, a weak CYP2E1 inducer and an inhibitor of OAT1/OAT3.
• Potential clinical impact of concomitant administration with CYP2C9 Substrates: increased systemic exposure of co-administered drugs metabolized by CYP2C9. Prevention or Management: reduce the dosage of the of co-administered drugs metabolized by CYP2C9 by half. Additional dosage adjustments may be needed to maintain therapeutic drug concentrations for narrow therapeutic index drugs.
• Potential clinical impact of concomitant administration with OAT1/OAT3 Substrates: increased exposure of these co-administered drugs. Prevention or Management: monitor for potential adverse reactions.

Use in Specific Populations:

Pregnancy: Limited available data with nitisinone use in pregnant women are not sufficient to determine a drug-associated risk of adverse developmental outcomes.

Lactation: The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for NITYR and any potential adverse effects on the breastfed infant from NITYR or
from the underlying maternal condition.

Pediatric Use: The safety and effectiveness of nitisinone have been established for the treatment of HT-1 in combination with dietary restriction of tyrosine and phenylalanine in pediatric patients. Use of NITYR for this indication is supported by evidence from one open-label, uncontrolled clinical study conducted with another oral formulation of nitisinone in 207 patients with HT-1 ages 0 to 22 years (median age 9 months).

Geriatric Use: Clinical studies of nitisinone did not include any subjects aged 65 and over. No pharmacokinetic studies of nitisinone have been performed in geriatric patients. In general, dose selection for an elderly patient should be cautious reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy in this patient population.

For more detailed information, please refer to the full Prescribing Information.

To report SUSPECTED ADVERSE REACTIONS contact Cycle Pharmaceuticals Ltd at 1-855-831-5413, or the FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch.

*NITYR® (nitisinone) Tablets are approved in the USA, Australia, New Zealand, the Kingdom of Saudi Arabia, the Kingdom of Morocco and Israel in 2, 5 and 10 mg strengths and in the UK and Egypt in 10 mg strength. Cycle Pharmaceuticals’ nitisinone products are also approved under a different name, NITISINONE TABLETS, in Canada in 2, 5, and 10 mg strengths. Registration conditions differ internationally.

Read the full NITYR PI

SAJAZIR™ (icatibant) Injection

Sajazir Logo

SAJAZIR is an FDA-approved injection indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults aged 18 years and older. 1

HAE is a rare and life-long, genetic condition that affects somewhere between 1 in 10,000–50,000 people.2,3,4 Patients may self-administer SAJAZIR upon recognition of symptoms of a HAE attack after training under the guidance of a health care professional.

For more information on SAJAZIR, please visit www.sajazir.com

Indications

SAJAZIRTM  (icatibant) injection is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.

Important Safety Information

Warnings and Precautions

Laryngeal Attacks. Given the potential for airway obstruction during acute laryngeal HAE attacks, patients should be advised to seek medical attention in an appropriate healthcare facility immediately in addition to treatment with SAJAZIR.

Adverse Reactions

The most commonly reported adverse reactions were injection site reactions, which occurred in almost all patients (97%) in clinical trials. Other common adverse reactions occurring in greater than 1% of patients included pyrexia (4%), transaminase increase (4%), dizziness (3%), and rash.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of icatibant: urticaria.

Drug Interactions:

ACE Inhibitors. Icatibant is a bradykinin B2 receptor antagonist and thereby has the potential to have a pharmacodynamic interaction with ACE inhibitors where icatibant may attenuate the antihypertensive effect of ACE inhibitors. Clinical trials to date have excluded subjects taking ACE inhibitors.

Use in Specific Populations

Pregnancy: Available data from published literature and the pharmacovigilance database with icatibant use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.

Lactation: The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for icatibant and any potential adverse effects on the breastfed child from icatibant or from the underlying maternal condition.

Pediatric Use: Safety and effectiveness in pediatric patients below the age of 18 years have not been established.

Geriatric Use: Elderly patients are likely to have increased systemic exposure to icatibant injection compared to younger (18-45 years) patients. No dose adjustment is recommended.

For more detailed information, please refer to the full Prescribing Information

To report SUSPECTED ADVERSE REACTIONS contact Cycle Pharmaceuticals at 1-800-836-4380, or the FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch.

References

  1. SAJAZIR™ (icatibant) Injection. Prescribing Information. Cycle Pharmaceuticals Limited.
  2. Maurer M, et al. Allergy. 2018;73(8):1575–1596.
  3. Zuraw BL, et al. J Allergy Clin Immunol Pract. 2013;1(5):458–467.
  4. El-Shanawany T. Hereditary Angioedema. British Society for Immunology. https://www.immunology.org/public-information/bitesized-immunology/immune-dysfunction/hereditary-angioedema (accessed October 2021).
Read the full SAJAZIR PI

JAVYGTOR™ (sapropterin dihydrochloride) Tablets and Powder for Oral Solution

Javygtor Logo

JAVYGTOR™ (sapropterin dihydrochloride) is indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). JAVYGTOR is to be used in conjunction with a Phe-restricted diet.

PKU is an inherited disorder caused by a deficiency of the phenylalanine hydroxylase (PAH) enzyme needed to process Phe, which is found in all foods containing protein.

For more information please visit www.javygtor.com

INDICATION
JAVYGTOR is indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). JAVYGTOR is to be used in conjunction with a Phe-restricted diet.

IMPORTANT SAFETY INFORMATION
Treatment with JAVYGTOR should be directed by physicians knowledgeable in the management of PKU. All patients with PKU who are being treated with JAVYGTOR should also be treated with a Phe-restricted diet, including dietary protein and Phe restriction. Prolonged exposure to elevated blood Phe levels can result in severe neurologic damage in PKU patients.

During treatment with JAVYGTOR, monitor blood Phe levels frequently to ensure adequate blood Phe level control, especially in pediatric patients. Also, active management of dietary Phe intake is required to ensure adequate Phe control and nutritional balance. Biochemical response to JAVYGTOR treatment should be determined through a therapeutic trial.

Patients should be advised to notify their physicians in cases of overdose.

WARNINGS AND PRECAUTIONS

  • Hypersensitivity Reactions Including Anaphylaxis: JAVYGTOR is not recommended in patients with a history of anaphylaxis to SAPROPTERIN DIHYDROCHLORIDE. Hypersensitivity reactions, including anaphylaxis and rash, have occurred. Signs of anaphylaxis include wheezing, dyspnea, coughing, hypotension, flushing, nausea, and rash. Discontinue JAVYGTOR treatment in patients who experience anaphylaxis, and initiate appropriate medical treatment. Continue dietary protein and Phe restrictions in patients who experience anaphylaxis.
  • Upper Gastrointestinal Mucosal Inflammation: Gastrointestinal (GI) adverse reactions suggestive of upper GI mucosal inflammation have been reported with JAVYGTOR. Serious adverse reactions included esophagitis and gastritis. If left untreated, these could lead to severe sequelae including esophageal stricture, esophageal ulcer, gastric ulcer, and bleeding, and such complications have been reported in patients receiving SAPROPTERIN DIHYDROCHLORIDE. Monitor patients for signs and symptoms of upper GI mucosal inflammation.
  • Hypophenylalaninemia: Some patients receiving SAPROPTERIN DIHYDROCHLORIDE have experienced hypophenylalaninemia (low blood Phe) during treatment. Children younger than 7 years old treated with JAVYGTOR doses of 20 mg/kg per day are at an increased risk for low levels of blood Phe compared with older patients.
  • Monitoring Blood Phe Levels During Treatment: Prolonged elevations of blood Phe levels in patients with PKU can result in severe neurologic damage, including severe intellectual disability, developmental delay, microcephaly, delayed speech, seizures, and behavioral abnormalities. Conversely, prolonged levels of blood Phe that are too low have been associated with catabolism and endogenous protein breakdown, which has been associated with adverse developmental outcomes. Active management of dietary Phe intake while taking sapropterin dihydrochloride is required to ensure adequate Phe control and nutritional balance. Monitor blood Phe levels during treatment to ensure adequate blood Phe level control. Frequent blood monitoring is recommended in the pediatric population.
  • Lack of Biochemical Response to JAVYGTOR: Not all patients with PKU respond to treatment with JAVYGTOR. Biochemical response to JAVYGTOR treatment cannot generally be pre-determined by laboratory testing (e.g., molecular testing), and should be determined through a therapeutic trial (evaluation) of JAVYGTOR response.
  • Interactions with Levodopa: There have been reports of interactions with levodopa causing seizures, exacerbation of seizures, over-stimulation, and irritability. Monitor patients who are receiving levodopa for a change in neurologic status during treatment with JAVYGTOR.#
  • Hyperactivity: There have been post-marketing reports of hyperactivity with administration of SAPROPTERIN DIHYDROCHLORIDE. Monitor patients for hyperactivity.

ADVERSE REACTIONS

  • Most common: The most common adverse reactions (incidence ≥4%) were headache, rhinorrhea, pharyngolaryngeal pain, diarrhea, vomiting, cough, and nasal congestion.

The following adverse reactions have been reported during post-approval use of sapropterin dihydrochloride:

  • Hypersensitivity reactions including anaphylaxis and rash. Most hypersensitivity reactions occurred within several days of initiating treatment;
  • Gastrointestinal reactions: esophagitis, gastritis, oropharyngeal pain, pharyngitis, esophageal pain, abdominal pain, dyspepsia, nausea, and vomiting;
  • Hyperactivity

DRUG INTERACTIONS

  • Levodopa – JAVYGTOR may increase the availability of tyrosine, a precursor of levodopa. Neurologic events were reported post-marketing in patients receiving sapropterin and levodopa concomitantly for a non-PKU indication. Monitor patients for a change in neurologic status.
  • Inhibitors of Folate Synthesis – Drugs that inhibit folate synthesis may decrease the bioavailability of endogenous BH4 by inhibiting the enzyme dihydrofolate reductase, which is involved in the recycling (regeneration) of BH4. This reduction in net BH4 levels may increase Phe levels. Frequently monitor blood Phe levels when co-administering JAVYGTOR with medications known to inhibit folate synthesis, such as methotrexate, valproic acid, phenobarbital, trimethoprim.
  • Drugs Affecting Nitric Oxide-Mediated Vasorelaxation – Both JAVYGTOR and PDE- 5 inhibitors (such as sildenafil, vardenafil, or tadalafil) may induce vasorelaxation. A reduction in blood pressure could occur. Monitor patients for hypotension when co-administering JAVYGTOR with medications known to affect nitric oxide–mediated vasorelaxation such as PDE-5 inhibitors.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: There are no well-controlled clinical studies of Sapropterin Dihydrochloride in pregnant women.
  • Lactation: There are insufficient data to assess the presence of sapropterin in human milk and no data on the effects on milk production.
  • Pediatric Use: Pediatric patients with PKU, ages 1 month to 16 years, have been treated with sapropterin dihydrochloride in clinical trials. The efficacy and safety of sapropterin dihydrochloride have not been established in neonates.
  • Geriatric Use: Clinical studies of sapropterin dihydrochloride in patients with PKU did not include patients aged 65 years and older. It is not known whether these patients respond differently than younger patients.
    For more detailed information, please refer to the full Prescribing Information at: www.JAVYGTOR.com/PI

To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy’s Laboratories, Inc. at 1-888-375-3784 or by email: medinfo@drreddys.com, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Read the full JAVYGTOR PI

TASCENSO ODT® (fingolimod)

Tascenso odt (r) (fingolimod) 0.25 mg and 0.5 mg ODT logo

TASCENSO ODT® (fingolimod) is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults and children 10 years of age and older.

MS is an unpredictable disease of the central nervous system that disrupts the neural signaling within the brain, and between the brain and body.

For more information, please visit www.tascenso.com

Indications

TASCENSO ODT is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older.

Contraindications

  • Patients who in the last 6 months experienced myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure with hospitalization, or Class III/IV heart failure.
  • Patients with a history or presence of Mobitz Type II 2nd degree or 3rd degree AV block or sick sinus syndrome, unless patient has a functioning pacemaker.
  • Patients with a baseline QTc interval ≥ 500 msec.
  • Patients with cardiac arrhythmias requiring anti-arrhythmic treatment with Class Ia or Class III anti-arrhythmic drugs.
  • Patients who had a hypersensitivity to fingolimod or any excipients in TASCENSO ODT.
  • Concomitant use with other products containing fingolimod.

Important Safety Information

Warnings and Precautions:

Due to a risk for bradyarrhythmia and AV blocks patients should be monitored during TASCENSO ODT treatment initiation. TASCENSO ODT may increase blood pressure, risk of infections and may cause fetal harm. Cases of Progressive Multifocal Leukoencephalopathy (PML) and of clinically significant liver injury have occurred in patients treated with fingolimod in the postmarketing setting. If PML is confirmed, treatment should be discontinued; Immune Reconstitution Inflammatory Syndrome (PML-IRIS) has been reported after discontinuation. TASCENSO ODT increases risk of macular edema. Rare cases of Posterior Reversible Encephalopathy Syndrome in adults have been reported with fingolimod. Fingolimod can have respiratory effects. Severe increase in disability accompanied by multiple new lesions on MRI has been reported following discontinuation of fingolimod. MS relapses with tumefactive demyelinating lesions on imaging have been observed during fingolimod therapy and after discontinuation. The risk of basal cell carcinoma and melanoma is increased in patients treated with fingolimod. Cases of lymphoma have been reported in patients receiving fingolimod. The reporting rate of non-Hodgkin lymphoma with fingolimod is greater than that expected in the general population. Fingolimod remains in the blood and has pharmacodynamic effects, including decreased lymphocyte counts for up to 2 months following the last dose. Hypersensitivity reactions including rash, urticaria, and angioedema have been reported with fingolimod. Cases of seizures, including status epilepticus, have been reported with the use of fingolimod.

Adverse Reactions:

In clinical trials, the most common adverse reactions (incidence ≥ 10% and >placebo) are headache, liver transaminase elevation, diarrhea, cough, influenza, sinusitis, back pain, abdominal pain, and pain in extremity.

Drug Interactions:

Patients on QT prolonging drugs with a known risk of torsades de pointes should be monitored during initiation of treatment with TASCENSO ODT. Monitor patients during use of systemic ketoconazole. Use of live attenuated vaccines during, and for 2 months after stopping TASCENSO ODT, should be avoided.

For more detailed information, please refer to the full Prescribing Information at www.tascenso.com/PI.

To report SUSPECTED ADVERSE REACTIONS, contact Cycle Pharmaceuticals Ltd at 1-888-533-1625 or the FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch.

Read the full TASCENSO ODT PI

ORMALVI™ (dichlorphenamide) Tablets

Ormalvi Logo

ORMALVI (dichlorphenamide) tablets are indicated for the treatment of primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and related variants.

Primary Periodic Paralysis (PPP) is a rare autosomal-dominant disease characterized by severe episodes of muscle weakness concomitant to variations in blood potassium levels.

For more information, please visit www.ormalvi.com

Indications
ORMALVI is an oral carbonic anhydrase inhibitor indicated for the treatment of primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and related variants.

Important Safety Information

Contraindications
• Hypersensitivity to dichlorphenamide or other sulfonamides
• Concomitant use of ORMALVI and high dose aspirin
• Severe pulmonary disease, limiting compensation to metabolic acidosis caused by ORMALVI
• Hepatic insufficiency: ORMALVI may aggravate hepatic encephalopathy

Warnings and Precautions

Hypersensitivity and Other Life-threatening Reactions
• Fatalities associated with the administration of sulfonamides have occurred because of adverse reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias.
• Pulmonary involvement can occur in isolation or as part of a systemic reaction.
• Discontinue ORMALVI at the first appearance of skin rash or any sign of immune-mediated or other life-threatening adverse reaction.

Concomitant Use of Aspirin or Other Salicylates
• Carbonic anhydrase inhibitors, including ORMALVI, can cause metabolic acidosis, which can increase the risk of salicylate toxicity.
• Anorexia, tachypnea, lethargy, and coma have been reported with concomitant use of dichlorphenamide and high-dose aspirin.
• Concomitant use of ORMALVI and high-dose aspirin is contraindicated. Use with caution and carefully monitor patients receiving low-dose aspirin.

Hypokalemia
• ORMALVI increases potassium excretion and can cause hypokalemia.
• The risk of hypokalemia is greater when ORMALVI is used in patients with conditions associated with hypokalemia (e.g., adrenocortical excess, renal tubular acidosis type 1 and 2), and in patients receiving other drugs that may case hypokalemia (e.g., loop diuretics, thiazide diuretics, laxatives, antifungals, penicillin, and theophylline).
• Baseline and periodic measurements of serum potassium during ORMALVI treatment are recommended.
• If hypokalemia develops or persists, consider reducing the dose or discontinuing ORMALVI and correction of potassium levels.

Metabolic Acidosis
• ORMALVI can cause hyperchloremic non-anion gap metabolic acidosis.
• Concomitant use of ORMALVI with other drugs that cause metabolic acidosis may increase the severity of acidosis.
• Concomitant use of ORMALVI in compensated patients with respiratory acidosis, such as in advanced lung diseases, may lead to respiratory decompensation.
• Baseline and periodic measurements of serum bicarbonate during ORMALVI treatment are recommended.
• If metabolic acidosis develops or persists, consider reducing the dose or discontinuing ORMALVI.

Falls
• ORMALVI increases the risk of falls; risk is greater in the elderly and with higher doses.
• Consider dose reduction or discontinuation of ORMALVI in patients who experience falls while treated with ORMALVI.

Pregnancy and Lactation
•Based on animal data, ORMALVI may cause fetal harm. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
•It is not known in humans whether dichlorphenamide is excreted in human milk; exercise caution when administered to a nursing woman.

Adverse Reactions: The most common adverse reactions seen in clinical trials (incidence ≥10% and greater than placebo) include paresthesias, cognitive disorder, dysgeusia, and confusional state.

Drug Interactions:
Aspirin: anorexia, tachypnea, lethargy, and coma have been reported with concomitant use of dichlorphenamide and high-dose aspirin. The concomitant use of ORMALVI and high-dose aspirin is contraindicated. ORMALVI should be used with caution in patients receiving lower doses of aspirin.

For more detailed information, please refer to the full Prescribing Information and at www.ORMALVI.com/PI

To report SUSPECTED ADVERSE REACTIONS, contact Cycle Pharmaceuticals Ltd at 1-857-437-3969, or the FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch.

Read the full ORMALVI PI
For NITYR® distribution information in the US market please contact +1-800-847-8714.
For NITYR® distribution information in Canada and all other markets please contact: sales-distribution@cyclepharma.com
To report an Adverse Event please click here
STATE REGULATIONS INFORMATION
Information for U.S. Colorado Prescribers of Prescription Drugs Provided Pursuant to Colorado House Bill 19-1131
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