PHARMACOKINETIC DATA ARE NOT A PREDICTOR OF CLINICAL EFFICACY OR SAFETY.

CAMBIA Achieves Peak Plasma Levels at 15 Minutes1

Measurable plasma levels were achieved within 5 minutes.1,2

  • Peak plasma levels were achieved at 15 minutes compared to diclofenac potassium immediate-release tablets1
  • High-fat food had no significant effect on CAMBIA absorption, but there was a reduction in peak plasma levels of approximately 70% after a high-fat meal. Decreased Cmax may be associated with decreased effectiveness1

PHARMACOKINETIC DATA ARE NOT A PREDICTOR OF CLINICAL EFFICACY OR SAFETY.

IMPORTANT SAFETY INFORMATION

DOSAGE AND ADMINISTRATION
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.

Non-Interchangeability with Other Formulations of Diclofenac
Different formulations of oral diclofenac are not 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.

50%

faster median time to maximum plasma concentration (Tmax) in the fasted state2*

77%

higher mean maximum plasma concentration (Cmax) in the fasted state2*

*In the fed state, CAMBIA resulted in an 80% faster median Tmax and a 21% lower Cmax than tablets.2

Mechanism of Delivery

PHARMACOKINETIC DATA ARE NOT A PREDICTOR OF CLINICAL EFFICACY OR SAFETY.

A Novel Formulation2

DBT_Graphic

CAMBIA is formulated with Dynamic Buffering Technology.3

  • Allows dissolution in water2
  • Combines diclofenac with a potassium bicarbonate buffer2
  • Contains a buffer that allows diclofenac to remain in solution when CAMBIA enters the stomach, and may be responsible for an improved pharmacokinetic profile2
    • Once mixed with water, the CAMBIA buffered preparation becomes ionized4
    • In the acidic environment of the stomach, the ionized diclofenac is protonated and ready to be absorbed into the bloodstream4
    • The protonated diclofenac potassium is then absorbed in the small intestine, rapidly achieving maximum concentration4
  • As a result, this formulation may lead to a shorter Tmax and a higher Cmax without an increase in overall systemic drug exposure (AUC)2
Interchangeability with Other Formulations of Diclofenac
Different formulations of oral diclofenac are not 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.

IMPORTANT SAFETY INFORMATION

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.

References

1. CAMBIA [package insert]. Newark, CA: Depomed, Inc; 2016. 2. Chen C, Bujanover S, Kareht S, Rapoport AM. Differential pharmacokinetics of diclofenac potassium for oral solution vs immediate-release tablets from a randomized trial: effect of fed and fasting conditions. Headache. 2015;55(2):265-275. 3. FDA approves Cambia™ for migraine. Montgomery, AL: Kowa Pharmaceuticals America, Inc.; June 22, 2009. 4. Chuasuwan B, Binjesoh V, Polli JE, et al. Biowaiver monographs for immediate-release solid oral dosage forms: diclofenac sodium and diclofenac potassium. J Pharm Sci. 2009;98(4):1216-1219.