Velmanase Alfa

Velmanase Alfa is a prescription medication used for the treatment of noncentral nervous system manifestations of alpha-mannosidosis in adult and pediatric patients.

• Velmanase Alfa is available under the following different brand names: Lamzede, Velmanase Alfa-tycv

Common side effects of Velmanase Alfa include:

• fever,
• chills,
• skin redness,
• vomiting,
• cough,
• hives,
• rash,
• pink or red eyes,
• swelling of the eyes or eyelids,   
• watery eyes,
• feeling like something is in the eye,
• itching, irritation, or burning of the eye,
• discharge from the eyes,
• crusting of the eyelids or lashes, and
• discomfort using contact lenses

Serious side effects of Velmanase Alfa include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• bluish or grayish color of the skin, nails, lips or around the eyes,
• low blood pressure,
• vomiting,
• skin redness,
• fever, and
• tremor

Rare side effects of Velmanase Alfa include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injection, lyophilized powder for reconstitution

• 10 mg/vial (single-dose)

Alpha-Mannosidosis

Adult and pediatric dosage

• 1 mg/kg (actual body weight) IV infusion every week

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Velmanase Alfa has no noted severe interactions with any other drugs.
• Velmanase Alfa has no noted serious interactions with any other drugs.
• Velmanase Alfa has no noted moderate interactions with any other drugs.
• Velmanase Alfa has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Velmanase Alfa?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Velmanase Alfa?”

Cautions

• Based on findings from animal reproduction studies, embryofetal harm when administered to pregnant females
• Infusion-related reactions
  • Infusion-associated reactions (IARs) reported
  • Symptoms include pyrexia, chills, erythema, vomiting, cough, urticaria, rash, and conjunctivitis
  • Similar symptoms were observed in adult and pediatric populations
  • Before administering, consider pretreating with antihistamines, antipyretics, and/or corticosteroids to reduce the risk of IARs
  • If a severe IAR occurs, discontinue immediately and initiate appropriate medical treatment; consider the risks and benefits of readministering following a severe IAR
  • May rechallenge using slower infusion rates
  • Once the patient tolerates the infusion, may increase the infusion rate to reach the recommended infusion rate
  • If a mild or moderate IAR occurs, consider slowing the infusion rate or temporarily withholding the dose
• Hypersensitivity reactions
  • Hypersensitivity reactions including anaphylaxis reported
  • Anaphylaxis and severe hypersensitivity signs and symptoms include cyanosis, hypotension, emesis, urticaria, erythema, facial swelling, pyrexia, and tremor
  • Before administration, consider pretreating with antihistamines, antipyretics, and/or corticosteroids
  • Ensure appropriate medical support measures, including cardiopulmonary resuscitation equipment, are readily available during the administration
  • If a severe hypersensitivity reaction (eg, anaphylaxis) occurs, discontinue immediately and initiate appropriate medical treatment; consider the risks and benefits of readministering following severe hypersensitivity reactions (including anaphylaxis)
  • Rechallenge using slower infusion rates
  • In patients with a severe hypersensitivity reactions, consider desensitization measures
  • If the infusion is tolerated, increase the rate to reach the recommended dosage
  • If a mild or moderate hypersensitivity reaction occurs, consider slowing the infusion rate or temporarily withholding the dose

Pregnancy and Lactation

• Based on findings from animal reproduction studies, embryofetal harm may occur when administered to pregnant females
• No data are available on use in pregnant females to evaluate a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes
• Advise pregnant females of potential risk to the fetus
• Consider need for treatment, potential drug-related risks to the fetus, and potential adverse outcomes from untreated maternal disease to continue or discontinue treatment during pregnancy
• Verify pregnancy status in females of reproductive potential
• Contraception
  • Females of reproductive potential: Use effective contraception during treatment and for 14 days after last dose
• Lactation
  • There are no data on the presence of Velmanase Alfa or its metabolite in either human or animal milk, effects on breastfed infants, or effects on milk production