Plasminogen, human-tvmh (Intravenous)

Plasminogen, human-tvmh injection is used to treat plasminogen deficiency type 1 (hypoplasminogenemia). It works by increasing the plasminogen levels in the blood.

This medicine is to be given only by your doctor or someone under their supervision.

It is very important that your doctor checks your progress closely while you are receiving this medicine. This will help your doctor see if the medicine is working properly and decide if you should continue to receive it. Blood and urine tests may be needed to check for unwanted effects.

Check with your doctor right away if you have any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, headache, dizziness, or weakness, pain, swelling, or discomfort in a joint, pinpoint red spots on your skin, unusual nosebleeds, or unusual vaginal bleeding that is heavier than normal. These may be symptoms of bleeding problems.

This medicine may cause tissue sloughing or shedding, which may lead to breathing problems, stomach or bowel problems, or urinating problems. Check with your doctor right away if you have blood in the urine or stools, cough or hoarseness, lower back or side pain, sore throat, trouble breathing, or voice changes.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, skin rash, trouble breathing, or unusual tiredness or weakness.

This medicine is made from donated human blood. Some human blood products have transmitted certain viruses (eg, Creutzfeldt-Jacob disease) to people who have received them, although the risk is low. Human donors and donated blood are both tested for viruses to keep the transmission risk low. Talk with your doctor if you have concerns about this risk.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use this medicine, you and your doctor will need to consider the risks and benefits. Here are important points to think about:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not shown any specific problems in children aged 11 months and older that would limit the use of plasminogen, human-tvmh injection. Safety and effectiveness have been established.

Geriatric

Studies have not been done to see how age affects the use of plasminogen, human-tvmh injection in older patients. Elderly patients are more likely to have kidney, liver, or heart issues related to age, which may require caution and dose adjustments for those taking this medicine.

Breast Feeding

There are no sufficient studies to determine the risk to infants when this medication is used during breastfeeding. Consider the potential benefits and risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction could happen. In such cases, your doctor may want to adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around mealtime or with specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines can also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect the use of this medicine. Be sure to tell your doctor if you have any other medical conditions, especially:

• Bleeding, active or
• Blood clots or
• Kidney disease or
• Lung or breathing problems or
• Stomach or bowel problems—Use with caution. May make these conditions worse.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Bleeding gums
• bloating
• constipation
• coughing up blood
• difficulty in breathing or swallowing
• dizziness
• headache
• increased menstrual flow or vaginal bleeding
• nausea
• nosebleeds
• paralysis
• prolonged bleeding from cuts
• red or black, tarry stools
• red or dark brown urine
• stomach pain

Incidence not known

• Chest pain or tightness
• cough or hoarseness
• fast heartbeat
• hives, itching, skin rash
• lower back or side pain
• lower stomach pain
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• sore throat
• unusual tiredness or weakness
• voice changes
• vomiting of blood or material that looks like coffee grounds

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Back, arm, or leg pain
• difficulty in moving
• dry mouth
• muscle pain or stiffness
• pain in the joints

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Ryplazim

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Blood Modifier Agent

Find detailed information on biosimilars for this medication.

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. It must be given slowly, so the needle should remain in place for 10 to 30 minutes. This medicine is usually given every 2 to 4 days.

This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.