tryngolza (autoinjector)
Tryngolza (Autoinjector) (Olezarsen Sodium) is a medication used to treat Hyperlipidemias, Hyperlipoproteinemia Type I.
Olezarsen Sodium · by Ionis Pharms Inc
Key facts
- Active ingredient
- Olezarsen Sodium
- Form
- Injectable
- Strength
- Olezarsen Sodium EQ 50MG BASE/0.8ML (EQ 50MG BASE/0.8ML) · Olezarsen Sodium EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML)
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- hyperlipidemias, hyperlipoproteinemia type i
- Manufacturer
- Ionis Pharms Inc
- FDA application
- NDA218614
What is Tryngolza (Autoinjector)?
From the FDA label:Olezarsen is an ASO directed inhibitor of apolipoprotein C-III (apoC-III) mRNA, conjugated to a ligand containing three GalNAc residues to enable delivery of the ASO to hepatocytes. TRYNGOLZA contains olezarsen sodium as the active ingredient. Olezarsen sodium is a white to yellow solid and it is freely soluble in water and in phosphate buffer. The molecular formula of olezarsen sodium is C 296 H 419 N 71 O 154 P 20 S 19 Na 20 and the molecular weight is 9124.48 daltons. The chemical name of olezarsen sodium is DNA, d(P-thio) ([2'- O -(2-methoxyethyl)] rA-[2'- O -(2-methoxyethyl)] rG-[2'- O -(2-methoxyethyl)] m5rC-[2'- O -(2-methoxyethyl)] m5rU-[2'- O -(2-methoxyethyl)] m5rU-m5C-T-T-G-T-m5C-m5C-A-G-m5C-[2'- O -(2-methoxyethyl)] m5rU-[2'- O -(2-methoxyethyl)] m5rU-[2'- O -(2-methoxyethyl)] m5rU-[2'- O -(2-methoxyethyl)] rA-[2'- O -(2-methoxyethyl)]m5rU), 5'-[26-[[2-(acetylamino)-2-deoxy-β-D-galactopyranosyl]oxy]-14,14-bis[[3-[[6-[[2-(acetylamino)-2-deoxy-β-D-galactopyranosyl]oxy]hexyl]amino]-3-oxopropoxy]methyl]-8,12,19-trioxo-16-oxa-7,13,20-triazahexacos-1-yl hydrogen phosphate], sodium salt (1:20). The structure of olezarsen sodium is presented below: TRYNGOLZA is a sterile, preservative-free solution for subcutaneous injection. Each single-dose autoinjector contains 50 mg olezarsen (equivalent to 53 mg of olezarsen sodium) in 0.8 mL of solution or 80 mg olezarsen (equivalent…
How to use
Adults with FCS: The recommended dosage of TRYNGOLZA is 80 mg injected subcutaneously once monthly. ( 2.1 ) Adults with sHTG: The recommended dosage of TRYNGOLZA is 50 mg injected subcutaneously once monthly. For patients with sHTG who tolerate the 50 mg dosage and additional TG reduction is clinically indicated, the dosage may be increased to 80 mg injected subcutaneously once monthly. ( 2.1 ) Inject TRYNGOLZA subcutaneously into the abdomen or front of the thigh. The back of the upper arm can also be used as an injection site if a healthcare provider or caregiver administers the injection. ( 2.2 ) 2.1 Recommended Dosage In adults with FCS: The recommended dosage of TRYNGOLZA is 80 mg injected subcutaneously once monthly [see Dosage and Administration (2.2) ] . In adults with sHTG: The recommended dosage of TRYNGOLZA is 50 mg injected subcutaneously once monthly [see Dosage and Administration (2.2) ]. Assess TG when clinically appropriate. The TG-lowering effect of TRYNGOLZA may be measured within 3 months after initiation. For patients who tolerate the 50 mg dosage and additional TG reduction is clinically indicated, the dosage may be increased to 80 mg injected subcutaneously once monthly. 2.2 Administration Instructions Prior to initiation, train patients and/or caregivers on proper preparation and administration of TRYNGOLZA [see Instructions for Use ] . Advise patients…
Side effects
The following clinically significant adverse reactions are discussed elsewhere in the labeling: Hypersensitivity Reactions [ see Warnings and Precautions (5.1) ] Liver Enzyme Abnormalities [see Warnings and Precautions (5.2) ] Most common adverse reactions in patients with FCS (incidence >5% of TRYNGOLZA-treated patients and >3% higher frequency than placebo) were injection site reactions, decreased platelet count, and arthralgia. ( 6.1 ) Most common adverse reactions in patients with sHTG (incidence ≥2% higher than placebo) were injection site reactions and liver enzyme increases. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ionis Pharmaceuticals, Inc. at toll free number 1-833-644-6647 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of TRYNGOLZA cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical Trial in Patients with FCS The safety of TRYNGOLZA was evaluated in 66 patients with FCS enrolled in Trial 1 (NCT #04568434) [see Clinical Studies (14.1) ] . In this trial, 43 patients received at least one dose of TRYNGOLZA, 50 mg (N=21) or 80 mg (N=22) and 23 patients received placebo. TRYNGOLZA 50 mg is not an approved dosing…
Warnings
Important safety information
Hypersensitivity Reactions: Have been reported in patients treated with TRYNGOLZA. Advise patients on the signs and symptoms of hypersensitivity reactions and instruct patients to promptly seek medical attention and discontinue use of TRYNGOLZA if hypersensitivity reactions occur. ( 5.1 ) Liver Enzyme Abnormalities: Increases in liver enzymes and hepatic fat have occurred in adults. Consider liver enzyme testing before TRYNGOLZA initiation or an increase in dosage and when clinically indicated thereafter. If persistent elevations in liver enzymes occur, consider dose interruption and/or dose reduction. If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue TRYNGOLZA. ( 5.2 ) 5.1 Hypersensitivity Reactions Hypersensitivity reactions (including symptoms of bronchospasm, diffuse erythema, facial swelling, urticaria, chills, and myalgias) have been reported in patients treated with TRYNGOLZA [see Adverse Reactions (6.1) ] . Advise patients on the signs and symptoms of hypersensitivity reactions and instruct patients to promptly seek medical attention and discontinue use of TRYNGOLZA if hypersensitivity reactions occur. TRYNGOLZA is contraindicated in patients with a history of serious hypersensitivity to olezarsen or any of the excipients in TRYNGOLZA. 5.2 Liver Enzyme Abnormalities TRYNGOLZA can cause increases in liver enzymes and hepatic fat in adults [see Adverse Reactions (6.1) ] . Increases in liver enzymes were more frequently reported with the 80 mg dose as compared to the 50 mg dose. In patients with sHTG, increases in liver enzymes greater than or equal to three times the upper limit of normal were reported more frequently with TRYNGOLZA 80 mg (7%) compared to TRYNGOLZA 50 mg (3%) and placebo (3%). Consider liver enzyme testing before TRYNGOLZA initiation or an increase in dosage and when clinically indicated thereafter. If persistent elevations in liver enzymes occur (such as three times the upper limit of normal or greater), consider dose interruption and/or dose reduction. If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue TRYNGOLZA.
Who should not take Tryngolza (Autoinjector)
TRYNGOLZA is contraindicated in patients with a history of serious hypersensitivity to olezarsen or any of the excipients in TRYNGOLZA. Hypersensitivity reactions, including symptoms of bronchospasm, diffuse erythema, facial swelling, urticaria, chills, and myalgias, requiring medical treatment have occurred [see Warnings and Precautions (5.1) ] . History of serious hypersensitivity reactions to olezarsen or any of the excipients in TRYNGOLZA. ( 4 )
May treat (source: NIH RxClass)
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
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Frequently asked questions
- What does Tryngolza (Autoinjector) treat?
- Tryngolza (Autoinjector) (Olezarsen Sodium) may be used to treat hyperlipidemias, hyperlipoproteinemia type i, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- Is there a coupon or discount for Tryngolza (Autoinjector)?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Tryngolza (Autoinjector). To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Tryngolza (Autoinjector)?
- Tryngolza (Autoinjector) is marketed by Ionis Pharms Inc. You can see Ionis Pharms Inc's full profile, rating, and other products on pharmaranks.
- Is Tryngolza (Autoinjector) a brand-name or generic drug?
- Tryngolza (Autoinjector) is a brand-name product with the active ingredient Olezarsen Sodium.
- Is Tryngolza (Autoinjector) available over the counter?
- No. Tryngolza (Autoinjector) is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Tryngolza (Autoinjector) come in?
- Tryngolza (Autoinjector) is currently marketed as injectable, per the FDA's National Drug Code Directory.
- Is Tryngolza (Autoinjector) FDA-registered?
- Tryngolza (Autoinjector) is on record with the U.S. FDA under application number NDA218614. You can verify this on its official FDA label.
- Is Tryngolza (Autoinjector) safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Tryngolza (Autoinjector). Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Tryngolza (Autoinjector)?
- Tryngolza (Autoinjector)'s side effects are taken directly from its FDA label. From the label: The following clinically significant adverse reactions are discussed elsewhere in the labeling: Hypersensitivity Reactions [ see Warnings and Precautions (5.1) ] Liver Enzyme Abnormalities [see Warnings and Precautions (5.2) ] Most common adverse reactions in patients with FCS (incidence >5% of TRYN… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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