Pronunciation:

plaz-MIN-oh-jen HUE-man - tvmh

Brand Names:

• Ryplazim

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Blood Modifier Agent

Uses of This Medicine:

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 or under the supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of plasminogen, human-tvmh injection in children 11 months of age and older. Safety and efficacy have been established.

Older adults—

Appropriate studies have not been performed on the relationship of age to the effects of plasminogen, human-tvmh injection in geriatric patients. Elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, 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.

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to 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 cause 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.

Side Effects of This Medicine:

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.