Using Cove's online telemedicine platform, patients complete a consultation with a licensed physician who can prescribe a variety of treatment options, including CAMBIA for a patient's acute treatment of migraine attacks with or without aura in adults and
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CAMBIA and
CAMBIA INDICATIONS AND USAGE
CAMBIA (diclofenac potassium) for oral solution is indicated for the acute treatment of migraine attacks with or without aura in adults (18 years of age or older).
Limitations of Use:
CAMBIA is not indicated for the prophylactic therapy of migraine.
The safety and effectiveness of CAMBIA have not been established for cluster headache.
SPRIX INDICATIONS AND USAGE
management of moderate to moderately severe pain that requires analgesia at the opioid level.
Limitations of Use
Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. The safety and effectiveness of a second dose have not been established. Different
formulations of oral diclofenac (e.g., CAMBIA, diclofenac sodium enteric-coated tablets, diclofenac sodium extended-release tablets, or diclofenac potassium immediate-release tablets) may not be bioequivalent even if the milligram strength is the same. Therefore, it is not possible to convert dosing from any other formulation of diclofenac to CAMBIA.
CONTRAINDICATIONS
CAMBIA is contraindicated in the following patients:
Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product.
History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients.
In the setting of coronary artery bypass graft (CABG) surgery.
WARNINGS AND PRECAUTIONS
Hepatotoxicity: Elevations of one or more liver tests may occur during therapy with CAMBIA. Postmarketing surveillance has reported cases of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Some of these reported cases resulted in fatalities or liver transplantation. Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop.
Hypertension: NSAIDs, including CAMBIA, can lead to new onset of hypertension or worsening of preexisting Hypertension. Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure.
Heart Failure and Edema: Avoid use of CAMBIA in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure. If CAMBIA is used in patients with severe heart failure, monitor patients for signs of worsening heart failure.
Renal Toxicity and Hyperkalemia: Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of an NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of CAMBIA in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function.
Increases in serum potassium concentration, including hyperkalemia, have been reported with use of NSAIDs, even in some patients without renal impairment.
Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs.
Exacerbation of Asthma Related to Aspirin Sensitivity: CAMBIA is contraindicated in patients with aspirin sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity).
Serious Skin Reactions: NSAIDs, including diclofenac, can cause serious skin adverse reactions which can be fatal. Discontinue CAMBIA at first appearance of skin rash or other signs of hypersensitivity.
Medication Overuse Headache: Detoxification may be necessary.
Premature Closure of Fetal Ductus Arteriosus: Avoid use in pregnant women starting at 30 weeks gestation.
Hematologic Toxicity: Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia.
ADVERSE REACTIONS
The most common adverse events (?1% and greater than placebo) in clinical trials with CAMBIA were nausea and dizziness.
DRUG INTERACTIONS
Drugs That Interfere with Hemostasis (e.g. warfarin, aspirin, SSRIs/SNRIs): Increased risk of serious bleeding with use of anticoagulants, antiplatelet agents, selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs). Monitor patients for bleeding who are concomitantly taking CAMBIA with drugs that interfere with hemostasis. Concomitant use of CAMBIA and analgesic doses of aspirin is not generally recommended.
ACE Inhibitors and ARBs: Concomitant use with CAMBIA in elderly, volume depleted, or those with renal impairment may result in deterioration of renal function. In such high risk patients, monitor for signs of worsening renal function.
Diuretics: NSAIDs can reduce natriuretic effect of loop and thiazide diuretics. Monitor patients to assure diuretic efficacy including antihypertensive effects.
Digoxin: Concomitant use with CAMBIA can increase serum concentration and prolong half-life of digoxin.
Monitor serum digoxin levels.
Inhibitors of Cytochrome P450 2C9: Diclofenac is metabolized predominantly by Cytochrome P-450 CYP2C9. During concomitant use of CAMBIA and drugs that inhibit CYP2C9, an increase in the duration between CAMBIA doses for subsequent migraine attacks may be necessary.
USE IN SPECIFIC POPULATIONS
Pregnancy: Use of NSAIDs during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs in pregnant women starting at 30 weeks gestation.
Infertility: NSAIDs are associated with reversible infertility. Consider withdrawal of CAMBIA in women who have difficulties conceiving.
CONTRAINDICATIONS
Known hypersensitivity to ketorolac or any components of the drug product.
History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients.
In the setting of coronary artery bypass graft (CABG) surgery.
Use in patients with active peptic ulcer disease or with recent gastrointestinal bleeding or perforation.
Use as a prophylactic analgesic before any major surgery.
Use in patients with advanced renal disease or patients at risk for renal failure due to volume depletion.
Use in labor and delivery. May adversely affect fetal circulation and inhibit uterine contractions, thus increasing the risk of uterine hemorrhage.
Use in patients with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis, or those for whom hemostasis is critical.
Concomitant use with probenecid or pentoxifylline.
Limitations of Use: The total duration of use of
ADVERSE REACTIONS
The most common adverse reactions (incidence ?2%) in patients treated with
USE IN SPECIFIC POPULATIONS
Pregnancy: Use of NSAIDs during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs in pregnant women starting at 30 weeks gestation.
Infertility: NSAIDs are associated with reversible infertility. Consider withdrawal of
Please see full Prescribing Information on SPRIX.com, including BOXED WARNING and MEDICATION GUIDE.
Contact:
T: 866-458-6389
FDA
T: 1-800-FDA-1088
Website: www.fda.gov/medwatch.
About Cove
Cove is a specialized healthcare company that offers personalized treatment solutions. Cove aims to empower patients by providing direct access to high-quality, affordable care, personalized to each customer and their specific needs. In addition to CAMBIA and
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