INDICATION AND IMPORTANT SAFETY INFORMATION
What are VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK?
- VOQUEZNA® TRIPLE PAK® (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and VOQUEZNA® DUAL PAK® (vonoprazan tablets, amoxicillin capsules) are co-packaged prescription medicines for the treatment of a Helicobacter pylori (H. pylori) bacterial infection in adults.
- It is not known if VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK are safe and effective in children.
- To reduce the development of drug-resistant bacteria and maintain the effectiveness of VOQUEZNA TRIPLE PAK, VOQUEZNA DUAL PAK and other antibacterial drugs, these products should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
Do not take VOQUEZNA TRIPLE PAK if you
- are known to have an allergy or be sensitive to the components of VOQUEZNA TRIPLE PAK (vonoprazan, amoxicillin, clarithromycin), macrolide antibiotics (such as azithromycin and erythromycin), or penicillin.
- are taking:
- medicines that contain rilpivirine (Edurant, Complera, Odefsey)
- colchicine, if you have kidney or liver problems
- lomitapide, lovastatin, and simvastatin
- ergot alkaloids (ergotamine or dihydroergotamine)
- have a history of yellowing of the skin (jaundice) or liver problems when taking clarithromycin.
Do not take VOQUEZNA DUAL PAK if you
- are known to have an allergy or be sensitive to the components of VOQUEZNA DUAL PAK (vonoprazan, amoxicillin) or penicillin.
- are taking medicines that contain rilpivirine (Edurant, Complera, Odefsey).
Before you take VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK, tell your healthcare provider about all of your medical conditions, including if you
- are breastfeeding. If breastfeeding, pump and discard breast milk during treatment and for 2 days after treatment.
- have severe kidney disease.
- have moderate to severe liver disease.
- have myasthenia gravis.
Additionally, do not take VOQUEZNA TRIPLE PAK if:
- you are pregnant or plan to become pregnant. Clarithromycin, a medicine in VOQUEZNA TRIPLE PAK may harm your unborn baby.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. There can be serious side effects when some are used in combination with this product. Serious adverse reactions can occur with VOQUEZNA TRIPLE PAK due to drug interactions of clarithromycin with colchicine, some lipid lowering agents, some calcium channel blockers, and other drugs.
What are the possible side effects of VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK?
VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK can cause serious side effects including:
- Allergic reactions (hypersensitivity): Call your doctor right away if you have rash, hives, or other skin changes, face swelling or difficulty breathing.
- Severe skin reactions: VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK can cause severe skin reactions, such as skin rash or allergic reaction on or in any part of your body. Symptoms can also include, but are not limited to, fever, chills, body aches or shortness of breath. If you experience any of these symptoms, stop taking VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK immediately and call your doctor right away.
- Severe diarrhea: Call your doctor right away if you have watery stools, stomach pain, and fever that does not go away while taking VOQUEZNA DUAL PAK or VOQUEZNA TRIPLE PAK or after therapy is completed.
- Rash in patients with mononucleosis: Amoxicillin (a component of VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK) may cause a rash in patients who have mononucleosis. Stop taking VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK if you are diagnosed with mononucleosis and call your doctor right away.
- Altered test results for some tumors: VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK lower stomach acid which can cause increased levels of a certain protein (CgA) in your blood. When this level is increased it may alter test results for detecting some tumors. Notify your doctor of the use of VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK prior to blood tests.
Additionally, VOQUEZNA TRIPLE PAK can cause:
- Irregular heartbeats: Clarithromycin may cause irregular heartbeats. Call your doctor right away if you feel faint, light-headed, or feel your heart beating irregularly.
- Liver problems: Call your doctor right away if you have any of the following symptoms: weight loss, yellowing of the skin and eyes (jaundice), dark urine, rash, or pain on the right side of your abdomen.
The most common side effects may include:
- temporary changes in sense of taste
- vaginal yeast infection
- stomach pain
- high blood pressure and
- cold-like symptoms
These are not all of the possible side effects of VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK. Call your doctor for medical advice about side effects.
You are encouraged to report suspected adverse reactions by contacting Phathom Pharmaceuticals at 1-888-775-PHAT (7428) or FDA
at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information for VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK.