INVOKANA PI PDF

Learn about INVOKANA®, an SGLT2 inhibitor that helps lower blood sugar and risk of cardiovascular disease in adults. See full Prescribing & Safety Info. INVOKANA is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an INVOKANA mg once daily who have an eGFR of 60 mL/min/ m2. INVOKANA® is now the only oral diabetes treatment approved to in the INVOKANA® U.S. full Prescribing Information (PI).3 The PI also.

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In clinical trials, approximately half of all patients experienced an infusion reaction. Most infusion reactions occurred during the imvokana infusion and were grade Infusion reactions can also occur with subsequent infusions.

Nearly all reactions occurred during infusion or within 4 hours of completing an infusion.

Canagliflozin, tablet, 100 mg and 300 mg, Invokana® – July 2013

Prior to the introduction of post-infusion medication in clinical trials, infusion reactions occurred up to 48 hours after infusion.

Severe reactions have occurred, including bronchospasm, hypoxia, dyspnea, hypertension, laryngeal edema and pulmonary edema. Signs and symptoms may include respiratory symptoms, such as nasal congestion, cough, throat irritation, as well as chills, vomiting and nausea. Less common symptoms were wheezing, allergic rhinitis, pyrexia, chest discomfort, pruritus, and hypotension.

Pre-medicate patients with antihistamines, antipyretics, and corticosteroids. Frequently monitor patients during the entire infusion. Interrupt infusion for reactions of any severity and institute medical management as needed. Permanently discontinue therapy if an anaphylactic reaction or life-threatening Grade 4 reaction occurs and institute appropriate emergency care. For patients with Grade 1, 2, or 3 reactions, reduce the infusion rate when re-starting the infusion.

Patients with a history of chronic obstructive pulmonary disease may require additional post-infusion medications to manage respiratory complications.

Consider prescribing short- and long-acting bronchodilators and inhaled corticosteroids for patients with chronic obstructive pulmonary disease. Daratumumab-mediated positive indirect antiglobulin test may persist for up to 6 months after the last daratumumab infusion. Monitor patients with neutropenia for signs of infection.

Indication and Important Safety Information | Janssen CarePath

Consider supportive care with growth factors. Consider supportive care with transfusions. Interference with Determination of Complete Response — Daratumumab is a human IgG kappa monoclonal antibody that can be detected on both the serum protein electrophoresis SPE and immunofixation IFE assays used for the clinical monitoring of endogenous M-protein.

This interference can impact the determination of complete response and of disease progression in some patients with IgG kappa myeloma protein. Effect of Daratumumab on Other Drugs: Please see full Prescribing Information. Please see full Prescribing Information for more details. Please refer to the full Prescribing Information or a complete list of adverse drug reactions.

Falls were invokanq associated with loss of consciousness or seizure. Evaluate patients for fracture and fall risk. Monitor and manage patients at risk for fractures according to established treatment guidelines and consider use of bone targeted agents. The onset of rash occurred at a median of 82 days. The median onset was day There were iinvokana Grade 3 or 4 adverse reactions. Thyroid replacement therapy, when clinically indicated, should be initiated or dose-adjusted.

Substitution for these medications is recommended when possible or evaluate for loss of activity if medication is continued. Postmarketing cases of metformin-associated lactic acidosis, including fatal infokana, were reported.

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These cases had a subtle onset and were accompanied by nonspecific symptoms such as malaise, myalgias, abdominal pain, respiratory distress, or increased somnolence; however, hypothermia, hypotension, and resistant bradyarrhythmias have occurred with severe acidosis. Prompt hemodialysis is recommended to correct the acidosis and remove accumulated metformin. Obtain an eGFR before initiation and at least annually thereafter, and more frequently in patients at increased risk of renal impairment.

More frequent invkkana is recommended when administered with drugs that impair renal invokanaa, result in hemodynamic change, interfere with acid-base balance, or increase metformin accumulation eg, cationic drugs. Radiological Studies with Contrast: Surgery and Other Procedures: The risk of lower-limb amputations was observed at both the mg and mg once-daily dosage regimens. Some patients had multiple amputations, some involving both lower limbs.

Lower-limb infections, gangrene, and diabetic foot ulcers were the most common precipitating medical events leading to the need for an amputation. The risk of amputation was highest in patients with a baseline history of prior amputation, peripheral vascular disease, and neuropathy.

Before initiating, consider factors in the patient history that may predispose to the need for amputations, such as a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers. Counsel patients about the importance of routine preventative foot care. Monitor patients for signs and symptoms of infection including osteomyelitisnew pain or tenderness, sores, or ulcers involving the lower limbs, and discontinue if invkana complications occur.

Acute kidney injury, requiring hospitalization and dialysis, has been reported; some reports involved patients younger than 65 years of age. Before initiation, consider factors that may predispose patients to acute kidney injury. If it occurs, promptly discontinue and treat. Evaluate renal function prior to initiation and periodically thereafter. A lower invokanaa of insulin or invokkana secretagogue may be required.

Metformin Hypoglycemia does not occur in patients receiving metformin alone under usual circumstances of use, but could occur when caloric intake is invoana, when strenuous exercise is not compensated by caloric supplementation, or when used concomitantly with other glucose-lowering agents such as sulfonylureas or insulin or ethanol.

Patients with pre-existing liver dysfunction, including chronic active hepatitis B or C, have an increased risk for liver function abnormalities, including severe hepatic adverse reactions. Drug-induced hepatitis and cases of liver injury, including some fatalities, innvokana been reported.

Severe skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms, and acute generalized exanthematous pustulosis have been reported in patients receiving invoakna coadministered with ritonavir.

Mild-to-moderate rash was also reported and often occurred and resolved with continued dosing. Effects on Serum Creatinine: Cobicistat decreases estimated creatinine clearance CrCl due to inhibition of tubular secretion of creatinine without affecting actual renal glomerular function.

Patients who experience a confirmed increase in serum creatinine of greater than 0. Consider alternative medications that do not require dosage adjustments in patients with renal impairment. Renal impairment, including cases of acute renal failure and Fanconi syndrome, has been reported with the use of tenofovir DF and cobicistat.

In all patients, monitor estimated CrCl, urine glucose, and urine protein prior to initiating and during therapy. Measure serum phosphorus in patients at risk of renal impairment. New onset or exacerbation of pre-existing diabetes mellitus and hyperglycemia have invokkana reported in patients receiving protease inhibitors.

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Invokanz or dose adjustments of insulin or oral hypoglycemic agents may be required. Increased bleeding in hemophiliacs has been reported in patients receiving protease inhibitors. Please refer invoakna the full Prescribing Information for a complete list onvokana adverse drug reactions. Post-marketing cases inbokana liver injury, including some fatalities, have been reported.

Discontinuation due to rash was 0.

However, rash that was considered drug related occurred at similar rates. These rashes were mild to moderate in severity and did not limit therapy; there were no discontinuations due to rash. This list of uses in specific populations is not complete. Please refer to the invvokana prescribing information for additional safety information.

A theoretical risk for transmission of Creutzfeldt-Jakob disease CJD also is considered extremely remote. Most ;i who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Approximately half of these cases were lymphomas, including Hodgkin’s and non-Hodgkin’s lymphoma. The other cases represented a variety of malignancies, including rare malignancies that are usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents.

The malignancies occurred after a median of 30 months after the first dose of therapy. Most of the patients were receiving concomitant immunosuppressants. These cases have had a very aggressive disease course and have been fatal. In clinical trials of all TNF inhibitors, more cases of lymphoma were invokwna compared with controls and the expected rate in the general population.

Cases of acute and chronic leukemia have been reported with postmarketing TNF-blocker use. As the potential role of TNF inhibitors in the development of malignancies is not known, caution should be exercised when considering treatment of patients with a current or a past history of malignancy or other risk factors such as chronic obstructive pulmonary disease COPD.

Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer. Patients should be monitored closely. Some cases were fatal.

For patients who test positive, consult a physician with expertise in the treatment of hepatitis B. Some cases were fatal or required liver transplant. Aminotransferase elevations were not noted prior to discovery of liver injury in many cases.

Invokana Insights: 10 Drug-Specific Facts You Should Know

Patients with symptoms invokanw signs of liver dysfunction should be evaluated for evidence of liver injury. Cases of leukopenia, neutropenia, thrombocytopenia, and pancytopenia some fatal have been reported.

Exercise caution in patients who have ongoing or a history of significant hematologic abnormalities. Advise patients to seek immediate medical attention if they develop signs and symptoms of blood dyscrasias or infection. Medications for the treatment of hypersensitivity reactions should be available. Monitor patients during infusion and if a serious reaction occurs, discontinue infusion. Manage reactions according to signs and symptoms.

Discontinue treatment if symptoms of a lupus-like syndrome develop. Care should be taken when switching from one biologic to another, since overlapping biological activity may further increase the risk of infection.