tyenne
Pharmaranks rates Tyenne 3.4/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Tyenne (Tocilizumab-Aazg) is a medication used to treat Cytokine Release Syndrome, Juvenile Arthritis, Rheumatoid Arthritis, Giant Cell Arteritis.
Tocilizumab-Aazg · by Fresenius Kabi USA
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Tocilizumab-Aazg
- Form
- Injectable, Solution
- Strength
- TOCILIZUMAB-AAZG 200MG/10ML · TOCILIZUMAB-AAZG 400MG/20ML · TOCILIZUMAB-AAZG 80MG/4ML
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Fresenius Kabi USA
- FDA application
- BLA761275
- FDA boxed warning
- Yes — see the boxed warning
What is Tyenne?
From the FDA label:Tocilizumab-aazg is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody of the immunoglobulin IgG1κ (gamma 1, kappa) subclass with a typical H 2 L 2 polypeptide structure. Each light chain and heavy chain consists of 214 and 448 amino acids (excluding the C-terminal lysine), respectively. The four polypeptide chains are linked intra- and inter-molecularly by disulfide bonds. Tocilizumab-aazg has a molecular weight of approximately 148 kDa. The antibody is produced in mammalian (Chinese hamster ovary) cells. Intravenous Infusion TYENNE (tocilizumab-aazg) injection is a sterile, clear and colorless to pale yellow, histidine buffered preservative-free solution with a pH of approximately 6 for further dilution prior to intravenous infusion. Each single-dose vial is available at a concentration of 20 mg/mL containing 80 mg/4 mL, 200 mg/10 mL, or 400 mg/20 mL of TYENNE. Each mL of solution contains arginine (17.4 mg), histidine (3.1 mg), lactic acid (0.9 mg), polysorbate 80 (0.2 mg), sodium chloride (0.6 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added to adjust the pH. Subcutaneous Injection TYENNE (tocilizumab-aazg) injection is a sterile, clear, colorless to pale yellow, preservative-free, histidine buffered solution with a pH of approximately 6 for subcutaneous use. It is supplied in a ready-to-use, single-dose…
How to use
Tyenne is sold in more than one form (Injectable and Solution), and each is dosed differently. The instructions below come from the FDA label for application BLA761275 — follow the label that came with the product you were actually prescribed.
For RA, pJIA and sJIA, TYENNE may be used alone or in combination with methotrexate; and in RA, other non-biologic DMARDs may be used. ( 2 ) General Administration and Dosing Information ( 2.1 ) • RA, GCA, PJIA and SJIA – It is recommended that TYENNE not be initiated in patients with an absolute neutrophil count (ANC) below 2,000 per mm 3 , platelet count below 100,000 per mm 3 , or ALT or AST above 1.5 times the upper limit of normal (ULN)( 5.3 , 5.4 ). • COVID-19 – It is recommended that TYENNE not be initiated in patients with an absolute neutrophil count (ANC) below 1,000 per mm 3 , platelet count below 50,000 mm 3 , or ALT or AST above 10 times ULN ( 5.3 , 5.4 ) . • In RA, CRS or COVID-19 patients, TYENNE doses exceeding 800 mg per infusion are not recommended. ( 2.2 , 2.9 , 12.3 ) • In GCA patients, TYENNE doses exceeding 600 mg per infusion are not recommended. ( 2.3 , 12.3 ) Rheumatoid Arthritis ( 2.2 ) Recommended Adult Intravenous Dosage: When used in combination with non-biologic DMARDs or as monotherapy the recommended starting dose is 4 mg per kg every 4 weeks followed by an increase to 8 mg per kg every 4 weeks based on clinical response. Recommended Adult Subcutaneous Dosage: Patients less than 100 kg weight 162 mg administered subcutaneously every other week, followed by an increase to every week based on clinical response Patients at or above 100 kg weight…
Side effects
The following serious adverse reactions are described elsewhere in labeling: • Serious Infections [see Warnings and Precautions ( 5.1 )] • Gastrointestinal Perforations [see Warnings and Precautions ( 5.2 )] • Laboratory Parameters [see Warnings and Precautions ( 5.4 )] • Immunosuppression [see Warnings and Precautions ( 5.5 )] • Hypersensitivity Reactions, Including Anaphylaxis [see Warnings and Precautions ( 5.6 )] • Demyelinating Disorders [see Warnings and Precautions ( 5.7 )] • Active Hepatic Disease and Hepatic Impairment [see Warnings and Precautions ( 5.8 )] Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not predict the rates observed in a broader patient population in clinical practice. Most common adverse reactions (incidence of at least 5%): upper respiratory tract infections, nasopharyngitis, headache, hypertension, increased ALT, injection site reactions. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience in Rheumatoid Arthritis Patients Treated with Intravenous Tocilizumab (tocilizumab-IV) The tocilizumab-IV data in rheumatoid arthritis (RA) includes 5 double-blind,…
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
Patients treated with tocilizumab products including TYENNE are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6.1 )] . Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt TYENNE until the infection is controlled. Reported infections include: • Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients, except those with COVID-19, should be tested for latent tuberculosis before TYENNE use and during therapy. Treatment for latent infection should be initiated prior to TYENNE use. • Invasive fungal infections, including candidiasis, aspergillosis, and pneumocystis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease. • Bacterial, viral and other infections due to opportunistic pathogens. The risks and benefits of treatment with TYENNE should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with TYENNE including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy [see Warnings and Precautions ( 5.1 )] . WARNING: RISK OF SERIOUS INFECTIONS See full prescribing information for complete boxed warning. • Serious infections leading to hospitalization or death including tuberculosis (TB), bacterial, invasive fungal, viral, and other opportunistic infections have occurred in patients receiving tocilizumab products. ( 5.1 ) • If a serious infection develops, interrupt TYENNE until the infection is controlled. ( 5.1 ) • Perform test for latent TB (except patients with COVID-19); if positive, start treatment for TB prior to starting TYENNE. ( 5.1 ) • Monitor all patients for active TB during treatment, even if initial latent TB test is negative. ( 5.1 )
Warnings
Important safety information
Serious Infections – do not administer TYENNE during an active infection, including localized infections. If a serious infection develops, interrupt TYENNE until the infection is controlled. ( 5.1 ) • Gastrointestinal (GI) perforation-use with caution in patients who may be at increased risk. ( 5.2 ) • Hepatotoxicity- Monitor patients for signs and symptoms of hepatic injury. Modify or discontinue TYENNE if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop. ( 2.10 , 5.3 ) • Laboratory monitoring-recommended due to potential consequences of treatment-related changes in neutrophils, platelets, lipids, and liver function tests. ( 2.10 , 5.4 ) • Hypersensitivity reactions, including anaphylaxis and death and serious cutaneous reactions including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) - discontinue TYENNE, treat promptly, and monitor until reaction resolves. ( 5.6 ) • Live vaccines-Avoid use with TYENNE ( 5.9 , 7.3 ) 5.1 Serious Infections Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, protozoal, or other opportunistic pathogens have been reported in patients receiving immunosuppressive agents including tocilizumab products. The most common serious infections included pneumonia, urinary tract infection, cellulitis, herpes zoster, gastroenteritis, diverticulitis, sepsis and bacterial arthritis [see Adverse Reactions ( 6.1 )] . Among opportunistic infections, tuberculosis, cryptococcus, aspergillosis, candidiasis, and pneumocystosis were reported with tocilizumab products. Other serious infections, not reported in clinical studies, may also occur (e.g., histoplasmosis, coccidioidomycosis, listeriosis). Patients have presented with disseminated rather than localized disease, and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids which in addition to rheumatoid arthritis may predispose them to infections. Do not administer TYENNE in patients with an active infection, including localized infections. The risks and benefits of treatment should be considered prior to initiating TYENNE in patients: • with chronic or recurrent infection; • who have been exposed to tuberculosis; • with a history of serious or an opportunistic infection; • who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or • with underlying conditions that may predispose them to infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with TYENNE, as signs and symptoms of acute inflammation may be lessened due to suppression of the acute phase reactants [see Dosage and Administration ( 2.1 ), Adverse Reactions ( 6.1 ), and Patient Counseling Information ( 17 )] . Hold TYENNE if a patient develops a serious infection, an opportunistic infection, or sepsis. A patient who develops a new infection during treatment with TYENNE should undergo a prompt and complete diagnostic workup appropriate for an immunocompromised patient, initiate appropriate antimicrobial therapy, and closely monitor the patient. COVID-19 In patients with COVID-19, monitor for signs and symptoms of new infections during and after treatment with TYENNE. There is limited information regarding the use of tocilizumab products in patients with COVID-19 and concomitant active serious infections. The risks and benefits of treatment with TYENNE in COVID-19 patients with other concurrent infections should be considered. Tuberculosis Evaluate patients for tuberculosis risk factors and test for latent infection prior to initiating TYENNE. In patients with COVID-19, testing for latent infection is not necessary prior to initiating treatment with TYENNE. Consider anti-tuberculosis therapy prior to initiation of TYENNE in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent tuberculosis but having risk factors for tuberculosis infection. Consultation with a physician with expertise in the treatment of tuberculosis is recommended to aid in the decision whether initiating anti-tuberculosis therapy is appropriate for an individual patient. Closely monitor patients for the development of signs and symptoms of tuberculosis including patients who tested negative for latent tuberculosis infection prior to initiating therapy. The incidence of tuberculosis in worldwide clinical development programs is 0.1%. Patients with latent tuberculosis should be treated with standard antimycobacterial therapy before initiating TYENNE. Viral Reactivation Viral reactivation has been reported with immunosuppressive biologic therapies and cases of herpes zoster exacerbation were observed in clinical studies with tocilizumab. No cases of Hepatitis B reactivation were observed in the trials; however patients who screened positive for hepatitis were excluded. 5.2 Gastrointestinal Perforations Events of gastrointestinal perforation have been reported in clinical trials, primarily as complications of diverticulitis in patients treated with tocilizumab. Use TYENNE with caution in patients who may be at increased risk for gastrointestinal perforation. Promptly evaluate patients presenting with fever, new onset abdominal symptoms, and a change in bowel habits for early identification of gastrointestinal perforation [see Adverse Reactions ( 6.1 )] . 5.3 Hepatotoxicity Serious cases of hepatic injury have been observed in patients taking intravenous or subcutaneous tocilizumab products. Some of these cases have resulted in liver transplant or death. Time to onset for cases ranged from months to years after treatment initiation with tocilizumab products. While most cases presented with marked elevations of transaminases (> 5 times ULN), some cases presented with signs or symptoms of liver dysfunction and only mildly elevated transaminases. During randomized controlled studies, treatment with tocilizumab was associated with a higher incidence of transaminase elevations [see Adverse Reactions ( 6.1 , 6.2 , 6.5 , 6.7 )]. Increased frequency and magnitude of these elevations was observed when potentially hepatotoxic drugs (e.g., MTX) were used in combination with tocilizumab. For RA and GCA patients, obtain a liver test panel (serum alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase, and total bilirubin) before initiating TYENNE, every 4 to 8 weeks after start of therapy for the first 6 months of treatment and every 3 months thereafter. It is not recommended to initiate TYENNE treatment in RA or GCA patients with elevated transaminases ALT or AST greater than 1.5x ULN. In patients who develop elevated ALT or AST greater than 5x ULN, discontinue TYENNE. For recommended modifications based upon increase in transaminases [see Dosage and Administration ( 2.10 )]. Patients hospitalized with COVID-19 may have elevated ALT or AST levels. Multi-organ failure with involvement of the liver is recognized as a complication of severe COVID-19. The decision to administer TYENNE should balance the potential benefit of treating COVID-19 against the potential risks of acute treatment with TYENNE. It is not recommended to initiate TYENNE treatment in COVID-19 patients with elevated ALT or AST above 10 x ULN. Monitor ALT and AST during treatment. Measure liver tests promptly in patients who report symptoms that may indicate liver injury, such as fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice. In this clinical context, if the patient is found to have abnormal liver tests (e.g., ALT greater than three times the upper limit of the reference range, serum total bilirubin greater than two times the upper limit of the reference range), TYENNE treatment should be interrupted and investigation done to establish the probable cause. TYENNE should only be restarted in patients with…
Who should not take Tyenne
TYENNE is contraindicated in patients with known hypersensitivity to tocilizumab products [see Warnings and Precautions ( 5.6 )]. Known hypersensitivity to tocilizumab products. ( 4 )
Overdose — what happens if you take too much
There are limited data available on overdoses with tocilizumab products. One case of accidental overdose was reported with intravenous tocilizumab in which a patient with multiple myeloma received a dose of 40 mg per kg. No adverse drug reactions were observed. No serious adverse drug reactions were observed in healthy volunteers who received single doses of up to 28 mg per kg, although all 5 patients at the highest dose of 28 mg per kg developed dose-limiting neutropenia. In case of an overdose, it is recommended that the patient be monitored for signs and symptoms of adverse reactions. Patients who develop adverse reactions should receive appropriate symptomatic treatment.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
7.1 Concomitant Drugs for Treatment of Adult Indications In RA patients, population pharmacokinetic analyses did not detect any effect of methotrexate (MTX), non-steroidal anti-inflammatory drugs or corticosteroids on tocilizumab clearance. Concomitant administration of a single intravenous dose of 10 mg/kg tocilizumab with 10-25 mg MTX once weekly had no clinically significant effect on MTX exposure. Tocilizumab products have not been studied in combination with biological DMARDs such as TNF antagonists [see Dosage and Administration ( 2.2 )] . In GCA patients, no effect of concomitant corticosteroid on tocilizumab exposure was observed. 7.2 Interactions with CYP450 Substrates Cytochrome P450s in the liver are down-regulated by infection and inflammation stimuli including cytokines such as IL-6. Inhibition of IL-6 signaling in RA patients treated with tocilizumab products may restore CYP450 activities to higher levels than those in the absence of tocilizumab products leading to increased metabolism of drugs that are CYP450 substrates. In vitro studies showed that tocilizumab has the potential to affect expression of multiple CYP enzymes including CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6 and CYP3A4. Its effect on CYP2C8 or transporters is unknown. In vivo studies with omeprazole, metabolized by CYP2C19 and CYP3A4, and simvastatin, metabolized by CYP3A4, showed up to a 28% and 57% decrease in exposure one week following a single dose of tocilizumab, respectively. The effect of tocilizumab products on CYP enzymes may be clinically relevant for CYP450 substrates with narrow therapeutic index, where the dose is individually adjusted. Upon initiation or discontinuation of TYENNE, in patients being treated with these types of medicinal products, perform therapeutic monitoring of effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) and the individual dose of the medicinal product adjusted as needed. Exercise caution when coadministering TYENNE with CYP3A4 substrate drugs where decrease in effectiveness is undesirable, e.g., oral contraceptives, lovastatin, atorvastatin, etc. The effect of tocilizumab products on CYP450 enzyme activity may persist for several weeks after stopping therapy [see Clinical Pharmacology ( 12.3 )] . 7.3 Live Vaccines Avoid use of live vaccines concurrently with TYENNE [see Warnings and Precautions ( 5.9 )] .
May treat (source: NIH RxClass)
Dosage forms
Injectable and Solution
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
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Frequently asked questions
- What does Tyenne treat?
- Tyenne (Tocilizumab-Aazg) may be used to treat cytokine release syndrome, juvenile arthritis, rheumatoid arthritis, giant cell arteritis, 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.
- How is Tyenne rated?
- pharmaranks gives Tyenne a composite score of 3.4 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Tyenne?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Tyenne. 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 Tyenne?
- Tyenne is marketed by Fresenius Kabi USA. You can see Fresenius Kabi USA's full profile, rating, and other products on pharmaranks.
- Is Tyenne a brand-name or generic drug?
- Tyenne is a brand-name product with the active ingredient Tocilizumab-Aazg.
- Is Tyenne available over the counter?
- No. Tyenne 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 Tyenne come in?
- Tyenne is currently marketed as injectable and solution, per the FDA's National Drug Code Directory.
- Is Tyenne FDA-registered?
- Tyenne is on record with the U.S. FDA under application number BLA761275. You can verify this on its official FDA label.
- Has Tyenne been recalled by the FDA?
- Tyenne has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Tyenne safe?
- There's no single safe-or-not verdict. pharmaranks gives Tyenne a recall-safety score of 68/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Tyenne?
- Tyenne's side effects are taken directly from its FDA label. From the label: The following serious adverse reactions are described elsewhere in labeling: • Serious Infections [see Warnings and Precautions ( 5.1 )] • Gastrointestinal Perforations [see Warnings and Precautions ( 5.2 )] • Laboratory Parameters [see Warnings and Precautions ( 5.4 )] • Immunosuppression [see Warn… 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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tyenne
68/100