lamzede
Lamzede (Velmanase Alfa-Tycv) is a medication used to treat Alpha-Mannosidosis.
Velmanase Alfa-Tycv · by Chiesi Farmaceutici Spa
Key facts
- Active ingredient
- Velmanase Alfa-Tycv
- Form
- Injectable
- Strength
- Velmanase ALFA-TYCV 10MG
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- alpha-mannosidosis
- Manufacturer
- Chiesi Farmaceutici Spa
- FDA application
- BLA761278
- FDA boxed warning
- Yes — see the boxed warning
What is Lamzede?
From the FDA label:Velmanase alfa-tycv, is lysosomal alpha-mannosidase produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells. The amino acid sequence of the monomeric protein is identical to the naturally occurring human enzyme, alpha-mannosidase. Velmanase alfa-tycv has an approximate molecular weight of 130 kDa. LAMZEDE (velmanase alfa-tycv) for injection is a sterile, preservative-free, white to off-white lyophilized powder with a cake-like appearance for intravenous infusion after reconstitution. Each single-dose vial contains 10 mg of velmanase alfa-tycv and the inactive ingredients dibasic sodium phosphate (2.47 mg), glycine (10.1 mg), mannitol (227.5 mg) and monobasic sodium phosphate (0.088 mg). After reconstitution with 5 mL Sterile Water for Injection, USP the resultant concentration is 2 mg/mL with pH of 7.5 ± 0.5.
How to use
For females of reproductive potential, verify that the patient is not pregnant prior to initiating treatment. ( 2.1 ) Consider pretreating with antihistamines, antipyretics, and/or corticosteroids prior to LAMZEDE administration. ( 2.2 ) Recommended LAMZEDE dosage is 1 mg/kg (actual body weight) administered once every week as an intravenous infusion. ( 2.2 ) See the full prescribing information for dosage modifications due to hypersensitivity reactions or IARs. ( 2.3 ) See the full prescribing information for reconstitution and administration instructions. ( 2.4 , 2.5 ) 2.1 Important Recommendations Prior to LAMZEDE Treatment Initiation For females of reproductive potential, verify that the patient is not pregnant [see Use in Specific Populations ( 8.1 , 8.3 )] . 2.2 Recommended Dosage and Administration Prior to LAMZEDE administration, consider pre-treating with antihistamines, antipyretics, and/or corticosteroids [see Warnings and Precautions ( 5.1 , 5.2 )] . The recommended dosage of LAMZEDE is 1 mg/kg (actual body weight) administered once every week as an intravenous infusion. The total volume of infusion is determined by the patient’s actual body weight and should be administered over a minimum of 60 minutes for patients weighing up to 49 kg. Patients weighing 50 kg and greater should be infused at a maximum infusion rate of 25 mL/hour to control the protein load [ s ee…
Side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions Including Anaphylaxis [see Warnings and Precautions ( 5.1 )] Infusion-Associated Reactions (IARs) [see Warnings and Precautions ( 5.2 ) ] Most common adverse reactions (incidence > 20%) are hypersensitivity reactions including anaphylaxis ( 5.1 ), nasopharyngitis, pyrexia, headache, and arthralgia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Chiesi USA, Inc. at 1-888-661-9260 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 a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions F rom Trial 1 The safety of LAMZEDE was evaluated in Trial 1, which included a total of 15 LAMZEDE-treated patients (8 adult patients aged 18-35 years old and 7 pediatric patients aged 6-17 years old; 9 male, 6 female) with alpha-mannosidosis [see Clinical Studies ( 14 )]. All patients received LAMZEDE 1 mg/kg weekly via intravenous infusion for 52 weeks. A serious adverse reaction of acute renal failure was reported in 1 (7%) LAMZEDE-treated patient (see Description of Selected Adverse Reactions) . Table 1 lists…
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
Hypersensitivity Reactions Including Anaphylaxis Patients treated with LAMZEDE have experienced hypersensitivity reactions, including anaphylaxis. Appropriate medical support measures, including cardiopulmonary resuscitation equipment , should be readily available during LAMZEDE administration. If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue LAMZEDE immediately and initiate appropriate medical treatment. In patients with severe hypersensitivity reaction, a desensitization procedure to LAMZEDE may be considered [see Warnings and Precautions ( 5.1 )]. WARNING: SEVERE HYPERSENSITIVITY REACTIONS See full prescribing information for complete boxed warning. Hypersensitivity Reactions Including Anaphylaxis Appropriate medical support measures, including cardiopulmonary resuscitation equipment , should be readily available. If a severe hypersensitivity reaction occurs, discontinue LAMZEDE immediately and initiate appropriate medical treatment. ( 5.1 )
Warnings
Important safety information
Infusion -Associ ated Reactions (IARs) : If severe IARs occur, discontinue LAMZEDE and initiate appropriate medical treatment. ( 5.2 ) Embryo - F etal Toxicity : May cause fetal harm. Advise females of reproductive potential to use effective contraception during treatment and for 14 days after the last dose if LAMZEDE is discontinued. ( 5.3 , 8.1 , 8.3 ) 5.1 Hypersensitivity Reactions Including Anaphylaxis Hypersensitivity reactions including anaphylaxis have been reported in LAMZEDE-treated patients. In clinical trials, 19 (50%) LAMZEDE-treated patients (5 adult patients and 14 pediatric patients) experienced hypersensitivity reactions, including 2 (5%) patients (1 adult patient and 1 pediatric patient) who experienced anaphylaxis and an additional 3 (8%) pediatric patients who experienced severe hypersensitivity reactions that required medical treatment [see Clinical Studies ( 14 )] . In the 5 patients who experienced anaphylaxis or severe hypersensitivity requiring medical treatment, 4 (80%) were anti-drug antibody (ADA) positive [see Clinical Pharmacology ( 12.6 ) ] . Anaphylaxis and severe hypersensitivity signs and symptoms included cyanosis, hypotension, emesis, urticaria, erythema, facial swelling, pyrexia, and tremor. Prior to LAMZEDE administration, consider pretreating with antihistamines, antipyretics, and/or corticosteroids. Appropriate medical support measures, including cardiopulmonary resuscitation equipment, should be readily available during LAMZEDE administration. If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue LAMZEDE immediately and initiate appropriate medical treatment. Consider the risks and benefits of re-administering LAMZEDE following severe hypersensitivity reactions (including anaphylaxis). Patients may be rechallenged using slower infusion rates. In patients with severe hypersensitivity reaction, desensitization measures to LAMZEDE may be considered. If the decision is made to readminister LAMZEDE, ensure the patient tolerates the infusion. If the patient tolerates the infusion, the rate may be increased to reach the recommended dosage. If a mild or moderate hypersensitivity reaction occurs, consider slowing the infusion rate or temporarily withholding the dose [see Dosage and Administration ( 2.3 )] . 5.2 Infusion-Associated Reactions Infusion-associated reactions (IARs) have been reported in LAMZEDE-treated patients. In clinical trials 19 (50%) LAMZEDE-treated patients (3 adult and 16 pediatric patients) experienced IARs. Of these 19 patients, 5 (13 % of all patients) required pretreatment in the clinical trials. One LAMZEDE-treated patient in clinical trials discontinued due to recurrent IARs. The most frequent symptoms of IARs that occurred in >10% of the population were pyrexia, chills, erythema, vomiting, cough, urticaria, rash and conjunctivitis. Similar symptoms were observed in adult and pediatric populations. Prior to LAMZEDE administration, consider pretreating with antihistamines, antipyretics, and/or corticosteroids to reduce the risk of infusion-associated reactions (IARs). However, IARs may still occur in patients after receiving pretreatment. If a severe IAR occurs, discontinue LAMZEDE immediately and initiate appropriate medical treatment. Consider the risks and benefits of readministering LAMZEDE following a severe IAR. Patients may be rechallenged using slower infusion rates. Once a patient tolerates the infusion, the infusion rate may be increased to reach the recommended infusion rate. If a mild or moderate IAR occurs, consider slowing the infusion rate or temporarily withholding the dose [see Dosage and Administration ( 2.3 )] . 5. 3 Embryo -F etal Toxicity Based on findings from animal reproduction studies, LAMZEDE may cause embryo-fetal harm when administered to a pregnant female. Administration of velmanase alfa-tycv to pregnant rats during the period of organogenesis caused skeletal and visceral malformations. In rats and rabbits, skeletal and visceral malformations were observed at exposures that were approximately 7- and 2.5-fold, respectively, those observed in patients treated at the recommended dose of 1 mg/kg. The decision to continue or discontinue LAMZEDE treatment during pregnancy should consider the female’s need for LAMZEDE, the potential drug-related risks to the fetus, and the potential adverse outcomes from untreated maternal disease. For females of reproductive potential, verify that the patient is not pregnant prior to initiating treatment with LAMZEDE. Advise females of reproductive potential to use effective contraception during treatment with LAMZEDE and for 14 days after the last dose if LAMZEDE is discontinued [see Use in Specific Populations ( 8.1 , 8.3 )].
Who should not take Lamzede
None. None. ( 4 )
Storing Lamzede, and how long it keeps
Quoted from this product’s own FDA label. Storage belongs to the product and its device, not to the drug in general — a pen and a tablet of the same medicine are kept completely differently.
- “Discard if not used within 10 hours.”
- “of the Reconstituted Solution If the reconstituted LAMZEDE vial is not used immediately, store the vial refrigerated at 2°C to 8°C (36°F to 46°F) for up to 24 hours inclusive of infusion time.”
May treat (source: NIH RxClass)
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
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Request a 90-day supply
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Use copay cards
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Frequently asked questions
- What does Lamzede treat?
- Lamzede (Velmanase Alfa-Tycv) may be used to treat alpha-mannosidosis, 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 Lamzede?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Lamzede. 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 Lamzede?
- Lamzede is marketed by Chiesi Farmaceutici Spa. You can see Chiesi Farmaceutici Spa's full profile, rating, and other products on pharmaranks.
- Is Lamzede a brand-name or generic drug?
- Lamzede is a brand-name product with the active ingredient Velmanase Alfa-Tycv.
- Is Lamzede available over the counter?
- No. Lamzede 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 Lamzede come in?
- Lamzede is currently marketed as injectable, per the FDA's National Drug Code Directory.
- Is Lamzede FDA-registered?
- Lamzede is on record with the U.S. FDA under application number BLA761278. You can verify this on its official FDA label.
- Is Lamzede safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Lamzede. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Lamzede?
- Lamzede's side effects are taken directly from its FDA label. From the label: The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions Including Anaphylaxis [see Warnings and Precautions ( 5.1 )] Infusion-Associated Reactions (IARs) [see Warnings and Precautions ( 5.2 ) ] Most common adverse reactions (incidenc… 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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