CAMBIA® (Potassium Diclofenac) | healthcare professional's home (2023)

INDICATIONS AND USE

IMPORTANT SAFETY NOTICE

DOSAGE AND APPLICATION

Use the lowest effective dose for the shortest time possible according to the patient's individual treatment goals. The safety and efficacy of a second dose have not been established.

Non-interchangeability with other diclofenac formulations

Different formulations of oral diclofenac are not bioequivalent, even if the concentration in milligrams is the same. Therefore, it is not possible to change the dosage of another formulation of diclofenac to CAMBIA.

CONTRAINDICATIONS

CAMBIA is contraindicated in the following patients:

• Known hypersensitivity (eg, anaphylactic reactions and severe skin reactions) to diclofenac or any other component of the drug
• History of asthma, hives or other allergic reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in these patients.
• As part of a coronary artery bypass graft (CABG) operation.

WARNINGS AND PRECAUTIONS

Cardiovascular thrombotic events

Clinical trials of up to three years' duration with various COX-2 selective and non-selective NSAIDs have demonstrated an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal.

To minimize the potential risk of an adverse cardiovascular event in patients treated with NSAIDs, use the lowest effective dose for the shortest duration possible. Physicians and patients should be alert to the development of such events during treatment, even in the absence of previous cardiovascular symptoms. Patients should be informed about the symptoms of serious cardiovascular events and the actions to be taken if they occur.

post MI patients

Avoid the use of CAMBIA in patients with recent myocardial infarction unless the benefit is expected to outweigh the risk of recurrent cardiovascular thrombotic events. If CAMBIA is used in patients with a recent myocardial infarction, patients should be monitored for signs of cardiac ischemia.

Gastrointestinal bleeding, ulceration and perforation

NSAIDs, including diclofenac, cause serious gastrointestinal (GI) adverse events, including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or colon, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients who develop a serious upper GI adverse event while on NSAID treatment is symptomatic.

See the full prescribing information for more information.

hepatotoxicity

Educate patients about the warning signs and symptoms of hepatotoxicity (eg, nausea, fatigue, lethargy, diarrhea, itching, jaundice, right upper quadrant tenderness, and "flu-like" symptoms). If clinical signs and symptoms consistent with liver disease develop or if systemic manifestations occur (eg, eosinophilia, rash, etc.), immediately discontinue CAMBIA and conduct a clinical evaluation of the patient.

To minimize the potential risk of a liver-related adverse event in patients treated with CAMBIA, use the lowest effective dose for the shortest duration possible.

hypertension

NSAIDs, including CAMBIA, may cause the return of hypertension or worsen pre-existing hypertension, both of which may contribute to an increased incidence of cardiovascular events. Use NSAIDs, including CAMBIA, with caution in patients with hypertension. Blood pressure should be carefully monitored at the start of treatment with NSAIDs and during treatment.

Patients taking angiotensin-converting enzyme (ACE) inhibitors, thiazides, or loop diuretics may respond poorly to these therapies when taking NSAIDs.

heart failure and edema

A meta-analysis of randomized controlled trials showed an approximately two-fold increase in hospitalizations for heart failure in patients treated selectively with COX-2 and in patients treated with non-selective NSAIDs compared with patients treated with placebo. In a study from the National Registry of Heart Failure Patients, NSAID use increased the risk of heart attack, hospitalization for heart failure, and death.

In addition, fluid retention and edema have been observed in some patients treated with NSAIDs. Administration of diclofenac may attenuate the cardiovascular effects of various therapeutic agents used to treat these conditions (e.g., diuretics, ACE inhibitors, or angiotensin receptor blockers [ARBs]).

Avoid using CAMBIA in patients with severe heart failure unless the benefit is expected to outweigh the risk of worsening heart failure. If CAMBIA is used in patients with severe heart failure, monitor patients for signs of worsening heart failure.

Kidney toxicity and hyperkalemia

kidney toxicity

Monitor renal function in patients with renal or hepatic impairment, congestive heart failure, dehydration, or hypovolemia. Avoid using CAMBIA in patients with advanced kidney disease unless the benefit is expected to outweigh the risk of worsening kidney function.

anaphylactic reactions

Diclofenac has been associated with anaphylactic reactions in patients with and without known hypersensitivity to diclofenac and in patients with aspirin-sensitive asthma. Get emergency help if an anaphylactic reaction occurs.

Asthma exacerbation associated with aspirin sensitivity

CAMBIA is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with pre-existing (aspirin-non-sensitive) asthma.

severe skin reactions

NSAIDs, including diclofenac, can cause serious skin side effects, including exfoliative dermatitis, Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can be fatal. These serious events can happen without warning.

CAMBIA should be discontinued at the first appearance of rash or other signs of hypersensitivity. CAMBIA is contraindicated in patients with a history of severe skin reactions to NSAIDs.

Medication overuse headache

Overuse of acute migraine medications (eg, ergotamine, triptans, opioids, nonsteroidal anti-inflammatory drugs, or a combination of these medications for 10 or more days a month) can lead to worsening of the headache (pain caused by medications). Medication overuse headaches can manifest as daily migraine-like headaches or as a marked increase in the frequency of migraine attacks. Patient detoxification may be necessary, including stopping drug abuse and treating withdrawal symptoms (often including a temporary worsening of the headache).

hematologic toxicity

Anemia has occurred in patients treated with NSAIDs. This may be due to gross or occult blood loss, fluid retention, or an incompletely described effect on erythropoiesis. If signs or symptoms of anemia develop in a patient treated with CAMBIA, hemoglobin or hematocrit should be monitored.

NSAIDs, including CAMBIA, may increase the risk of bleeding events. Concomitant use of warfarin and other anticoagulants, antiplatelet agents (eg. Monitor these patients and any patients who may be compromised by platelet dysfunction for signs of bleeding.

SIDE EFFECTS

The most common adverse reactions (≥ 1% and greater than placebo) in clinical trials with CAMBIA were nausea and dizziness.

INTERACTIONS WITH OTHER MEDICINES

Medications that affect hemostasis (eg, warfarin, aspirin, SSRIs/SNRIs):
Monitor patients taking CAMBIA concomitantly with medications that interfere with bleeding control. In general, the concomitant use of CAMBIA and analgesic doses of aspirin is not recommended.

ACE inhibitors and ARBs

Concomitant use with CAMBIA in elderly patients with volume depletion or renal insufficiency may result in renal failure. In such high-risk patients, watch for signs of deteriorating kidney function.

diuretics

NSAIDs may decrease the natriuretic effects of loop and thiazide diuretics. Monitor patients to ensure diuretic efficacy, including antihypertensive effects.

digoxin

Concomitant use with CAMBIA may increase serum concentrations and prolong the half-life of digoxin. Monitor serum digoxin levels.

For complete information on drug interactions, see the complete prescribing information.

USE IN CERTAIN POPULATIONS

application in pregnancy

Based on animal data, may cause fetal harm. Based on human data, CAMBIA should be avoided after 30 weeks of gestation as it may cause premature closure of the ductus arteriosus in the fetus. CAMBIA should be used during pregnancy less than 30 weeks gestation only if the potential benefit outweighs the risk to the fetus (category C). After 30 weeks, CAMBIA can cause fetal harm (category D).

Mother who breastfeeds:

Use with caution as it is not known whether diclofenac is excreted in human milk.

pediatric use

Safety and efficacy in pediatric patients have not been established.

geriatric use

Elderly patients are at increased risk of serious cardiovascular, gastrointestinal and/or renal adverse reactions associated with NSAIDs compared to younger patients. If the expected benefits for the elderly patient outweigh these potential risks, initiate dosing at the lower end of the dosing range and monitor patients for side effects.

liver dysfunction

As nearly 100% of diclofenac elimination is hepatic, patients with hepatic impairment should only be considered for treatment with CAMBIA if the benefits outweigh the risks.

renal insufficiency

CAMBIA treatment is not recommended in patients with advanced renal disease.

Please see in fullprescribing informationincluding NOTICE ON THE BOX andmedication guideLearn more about CHANGE.

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