Brand Name
Orlynvah
Generic Name
Sulopenem Etzadroxil
View Brand Information FDA approval date: March 20, 2025
Form: Tablet
What is Orlynvah (Sulopenem Etzadroxil)?
ORLYNVAH a combination of sulopenem etzadroxil, a penem antibacterial, and probenecid, a renal tubular transport inhibitor, is indicated for the treatment of uncomplicated urinary tract infections caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options.
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Brand Information
ORLYNVAH (sulopenem etzadroxil and probenecid)
1DOSAGE FORMS AND STRENGTHS
ORLYNVAH (sulopenem etzadroxil 500 mg and probenecid 500 mg) tablets are supplied as pink, oval-shaped, film-coated, fixed-dose, bilayer combination tablets debossed with SULO on one side and plain on the other side.
2CONTRAINDICATIONS
ORLYNVAH is contraindicated in patients with:
- A history of hypersensitivity to the components of ORLYNVAH (sulopenem etzadroxil and probenecid) or other beta-lactam antibacterial drugs
- Known blood dyscrasias
- Known uric acid kidney stones
Concomitant use of ORLYNVAH and ketorolac tromethamine is contraindicated
3ADVERSE REACTIONS
The following adverse reactions are described in greater detail in the Warnings and Precautions section.
- Hypersensitivity Reactions
- Clostridioidesdifficile-Associated Diarrhea [seeWarningsandPrecautions(5.2)]
- Risk of Uric Acid Kidney Stone Development
- Exacerbation of Gout
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect rates observed in practice.
ORLYNVAH was evaluated in two Phase 3 controlled, multinational, randomized, double blind, double dummy clinical trials (Trial 1 and Trial 2) in adult women with uUTI. Therapy with oral ORLYNVAH tablets was administered as one tablet twice daily for 5 days
Serious Adverse Reactions and Adverse Reactions Leading to Discontinuation
Serious adverse reactions occurred in 6/1932 (0.3%) of uUTI patients treated with ORLYNVAH and in 2/822 (0.2%) and 5/1107 (0.5%) of patients treated with ciprofloxacin or amoxicillin/clavulanate, respectively. Treatment discontinuation due to an adverse reaction occurred in 21/1932 (1%) of patients treated with ORLYNVAH, 8/822 (1%) of patients treated with ciprofloxacin, and 4/1107 (0.4%) of patients treated with amoxicillin/clavulanate. The most commonly reported adverse reactions leading to discontinuation of ORLYNVAH were nausea (6/1932; 0.3%), diarrhea (5/1932; 0.3%), as well as abdominal pain, gastroesophageal reflux disease, vomiting, and dizziness, each 0.2% (3/1932).
Most Common Adverse Reactions
Adverse reactions occurring at 2% or greater in patients receiving ORLYNVAH were diarrhea, nausea, vulvovaginal mycotic infection, headache, and vomiting.
Table 1 lists adverse reactions reported in ≥ 1% of patients receiving ORLYNVAH in the phase 3 uUTI trials (Trial 1 and Trial 2). The most common adverse reactions in patients treated with ORLYNVAH were diarrhea (10%) and nausea (4%).
a ORLYNVAH tablets (sulopenem etzadroxil 500mg / probenecid 500mg) 1 tablet twice daily for 5 days; bAmoxicillin/clavulanate tablets (875 mg /125 mg) 1 tablet twice daily for 5 days cCiprofloxacin tablets (250 mg) 1 tablet twice daily for 3 days.
1 Diarrhea includes diarrhea and loose stools.
2 Vulvovaginal mycotic infection includes vulvovaginal mycotic infection, vulvovaginal candidiasis, vaginal infection, fungal infection, genital infection fungal, and yeast infection.
3Abdominal pain includes abdominal pain, abdominal pain lower, abdominal pain upper, and abdominal discomfort.
1 Diarrhea includes diarrhea and loose stools.
2 Vulvovaginal mycotic infection includes vulvovaginal mycotic infection, vulvovaginal candidiasis, vaginal infection, fungal infection, genital infection fungal, and yeast infection.
3Abdominal pain includes abdominal pain, abdominal pain lower, abdominal pain upper, and abdominal discomfort.
Other Adverse Reactions of ORLYNVAH
The following selected adverse reactions were reported in the ORLYNVAH-treated patients at a rate of < 1% in the uUTI Trial 1 and Trial 2:
Cardiac disorders:tachycardia
Ear and labyrinth disorders: vertigo
Gastrointestinal disorders:abdominal distension, abnormal feces, constipation, dry mouth, dyspepsia, eructation, feces discolored, feces soft, flatulence, gastroesophageal reflux disease
General disorders:asthenia,fatigue, malaise, peripheral edema, pain, pyrexia
Hepatobiliary disorders: elevated transaminases, hepatomegaly
Infections and infestations: bacterial vaginosis, Candida infection, candiduria
Metabolism and nutrition disorders: polydipsia
Musculoskeletal and connective tissue disorders: arthralgia, back pain, myositis
Nervous system disorders:ageusia,dizziness, dysgeusia, dystonia, migraine, paresthesia, presyncope, somnolence, syncope
Psychiatric disorders: confusion
Renal and urinary disorders: urine odor abnormal
Reproductive system and breast disorders:perineal pain, vaginal discharge, vulvovaginal pruritus
Respiratory disorders:cough, dyspnea
Skin and subcutaneous tissue disorders: angioedema, pruritus, rash
Vascular disorders: flushing, hypertension
Ear and labyrinth disorders: vertigo
Gastrointestinal disorders:abdominal distension, abnormal feces, constipation, dry mouth, dyspepsia, eructation, feces discolored, feces soft, flatulence, gastroesophageal reflux disease
General disorders:asthenia,fatigue, malaise, peripheral edema, pain, pyrexia
Hepatobiliary disorders: elevated transaminases, hepatomegaly
Infections and infestations: bacterial vaginosis, Candida infection, candiduria
Metabolism and nutrition disorders: polydipsia
Musculoskeletal and connective tissue disorders: arthralgia, back pain, myositis
Nervous system disorders:ageusia,dizziness, dysgeusia, dystonia, migraine, paresthesia, presyncope, somnolence, syncope
Psychiatric disorders: confusion
Renal and urinary disorders: urine odor abnormal
Reproductive system and breast disorders:perineal pain, vaginal discharge, vulvovaginal pruritus
Respiratory disorders:cough, dyspnea
Skin and subcutaneous tissue disorders: angioedema, pruritus, rash
Vascular disorders: flushing, hypertension
Adverse Reactions Occurring with Probenecid (a component of ORLYNVAH)
The following adverse reactions associated with the use of probenecid (a component of ORLYNVAH) were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Adverse reactions not observed in clinical studies of ORLYNVAH that have been observed with probenecid (a component of ORLYNVAH) include:
4OVERDOSAGE
There is no information on clinical signs and symptoms associated with an overdose of ORLYNVAH. No clinical information is available on the use of hemodialysis to treat ORLYNVAH overdosage.
5DESCRIPTION
ORLYNVAH
The chemical name of sulopenem etzadroxil is 4-Thia-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid, 6-[(1
Figure 1. Sulopenem Etzadroxil Chemical Structure and Formula
The chemical name for probenecid is 4-[(dipropylamino) sulfonyl] benzoic acid. See Figure 2 for probenecid chemical structure and chemical formula. The molecular weight of probenecid is 285.36 g/mol.
Figure2. Probenecid Chemical Structure andFormula
ORLYNVAH are pink bilayer tablets for oral use containing 500 mg of sulopenem etzadroxil and 500 mg of probenecid and the following inactive ingredients: croscarmellose sodium, hydroxypropylcellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The film coating contains carmine, lecithin polyvinyl alcohol, talc, titanium dioxide, and xanthan gum.
6PATIENT COUNSELING INFORMATION
Allergic Reactions
Advise patients that allergic reactions, including serious allergic reactions, could occur, and that serious allergic reactions require immediate treatment. Patients should inform their healthcare provider about any previous hypersensitivity reactions to ORLYNVAH, other beta-lactam antibacterial drugs or probenecid
Diarrhea
Advise patients that diarrhea is a common problem caused by antibacterial drugs, including ORLYNVAH, and usually resolves when the drug is discontinued. Sometimes, frequent watery or bloody diarrhea may occur and may be a sign of a more serious intestinal infection. If severe watery or bloody diarrhea develops, patients should contact their healthcare provider
Antibacterial Resistance
Patients should be counseled that ORLYNVAH should only be used to treat proven or strongly suspected susceptible uUTI. Antibacterial drugs do not treat viral infections (e.g., the common cold). When ORLYNVAH is prescribed to treat proven or strongly suspected susceptible uUTI, patients should be told that although it is common to feel better early in the course of therapy, ORLYNVAH should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment, and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by ORLYNVAH or other antibacterial drugs in the future
Ketoprofen
Advise patients that concomitant use of ketoprofen with ORLYNVAH is not recommended
Manufactured for: Iterum Therapeutics U.S. Limited, Chicago, IL 60606
US Patent Numbers: Available online at
ORLYNVAH
7PRINCIPAL DISPLAY PANEL
NDC 81153-100-01
