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Overview: Orlynvah is used to treat certain bladder infections. The most common side effects are headache, diarrhea, nausea, and vomiting. Talk with your healthcare provider right away if you get severe diarrhea even after you finish this medicine. Take all of your doses, even if your symptoms get better or go away. This will reduce the risk that future infections are resistant to Orlynvah or other similar medicines.

Uses

What is Orlynvah used for?

Orlynah (sulopenem/probenecid) is commonly used to treat bladder infections caused by certain bacteria.

Orlynvah may not be appropriate for some of the infections listed above, depending on which bacteria are causing the infection. Bacteria in some locations may have developed resistance to Orlynvah, which will make it not work as well.

Orlynvah may also be used for other conditions as determined by your healthcare provider.

How does Orlynvah work (mechanism of action)?

Orlynvah has two medicines in it, probenecid and sulbopenem. Probenecid helps to keep sulbopenem in your body longer. Sulopenem kills the bacteria causing the infection by binding to a specific protein in the bacteria.

How is Orlynvah supplied (dosage forms)?

Brands and other names

  • Orlynvah

Dosage forms and strengths

  • 500 mg/500 mg oral tablets

How should I store Orlynvah?

Orlynvah should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.

Side Effects

What are the most common side effects of Orlynvah?

The most common side effects of Orlynvah are listed below. Tell your healthcare provider if you have any of these side effects that bother you.

  • Diarrhea
  • Nausea and vomiting
  • Vaginal fungus or yeast infection
  • Headache

There may be other side effects of Orlynvah that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Orlynvah?

While less common, the most serious side effects of Orlynvah are described below, along with what to do if they happen.

Severe Allergic Reactions. Orlynvah may cause allergic reactions, which can be serious. Stop taking Orlynvah and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Antibiotic-associated Diarrhea. An overgrowth of germs called Clostridioides difficile, or “C. diff,” can happen in your gut with many types of antibiotics, including Orlynvah. This can cause a condition known as antibiotic-associated diarrhea and can happen even up to 2 months after stopping the antibiotic. Call your healthcare provider right away if you have any of the following symptoms of this condition.

  • Watery diarrhea
  • Diarrhea that does not go away
  • Blood in your stool (poop)
  • Severe stomach cramps
  • Fever that starts after you start or finish the medicine

Warnings & Precautions

Who should not use Orlynvah?

Allergies to Ingredients. People who are allergic to any of the following should not take Orlynvah.

  • Orlynvah
  • Sulopenem
  • Probenecid
  • Any other medicine known as a beta-lactam
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Orlynvah.

Drug Interactions. Orlynvah should not be taken while you are using certain other medicines. Before taking Orlynvah, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Blood Disorders. People who have any blood disorders, known as blood dyscrasias, should not take Orlynvah. Some examples of blood disorders include anemia, leukopenia (low white blood cells), and thrombocytopenia (low platelets). Tell your healthcare provider if you have any blood disorders.

Uric Acid Kidney Stones. People who currently have kidney stones that are made of uric acid should not take Orlynvah. Tell your healthcare provider if you have had, or currently have, any type of kidney stone.

What should I know about Orlynvah before using it?

Do not take Orlynvah unless it has been prescribed to you by a healthcare provider. Take it as prescribed. 

Do not share Orlynvah with other people, even if they have the same condition as you. It may harm them.

Keep Orlynvah out of the reach of children.

You should take Orlynvah with food. 

What should I tell my healthcare provider before using Orlynvah?

Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Orlynvah is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your healthcare provider if you have any of the following.

  • Gout
  • Kidney problems

Pregnancy. It is not known if or how Orlynvah could affect pregnancy or harm an unborn baby. Tell your healthcare provider if you are or plan to become pregnant.

Breastfeeding. It is not known if Orlynvah passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should take Orlynvah while breastfeeding.

How can I get more information about Orlynvah?

For more information about Orlynvah, you can visit the manufacturer’s website at www.iterumtx.com.

Interactions

Does Orlynvah interact with foods or drinks?

There are no known interactions between Orlynvah and foods or drinks.

It is unknown if drinking alcohol will affect Orlynvah, but heavy drinking can slow your immune response and make it harder for your body to fight infection. 

Does Orlynvah interact with other medicines (drug interactions)?

Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking Orlynvah.

  • A nonsteroidal anti-inflammatory drug (NSAID), such as indomethacin, naproxen, ketorolac, ketoprofen, and others, which is in many prescription and OTC products for pain, swelling, and fever
  • Methotrexate (Trexall and others), which is a medicine commonly used for rheumatoid arthritis or certain types of cancer
  • Rifampin, which is a medicine commonly used to treat an infection called tuberculosis
  • Lorazepam (Ativan and others), which is a medicine used for anxiety, muscle spasms, or seizures
  • A sulfonylurea, such as glipizide (Glucotrol XL) or glimepiride (Amaryl), which is a medicine commonly used for diabetes 

Some other medicines may alter the blood levels of Orlynvah, and vice versa. Tell your healthcare provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Orlynvah. Always check with your healthcare provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Orlynvah?

If you or someone else has used too much Orlynvah, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Orlynvah?

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses. 

It is important to complete your prescribed course of Orlynvah, even if your symptoms get better or go away. This will reduce the risk that future infections are resistant to Orlynvah or other similar medicines.