Description
Alpha-1 proteinase inhibitor injection, also called alpha 1-PI, is used to treat a certain type of emphysema (a lung condition). The emphysema is caused by the lack of a protein called alpha 1-antitrypsin (AAT) in the body. This medicine replaces the protein when the body does not produce enough.
This medicine is to be given only by or under the immediate supervision of your doctor.
This product is available in the following dosage forms:
- Powder for Solution
- Solution
Before Using
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.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of alpha-1 proteinase inhibitor in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies have not been performed on the relationship of age to the effects of alpha-1 proteinase inhibitor in the geriatric population. Safety and efficacy have not been established.
Breastfeeding
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.
Drug Interactions
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:
- IgA deficiency with antibodies against IgA—Should not be used in patients with this condition.
Proper Use
A nurse or other trained health professional will give you this medicine in a hospital or clinic setting. This medicine is given through a needle placed in one of your veins.
This medicine is usually given once a week on a regular schedule. If you have any questions about this, check with your doctor.
You may be taught how to give your medicine at home. Make sure you understand all instructions before you give yourself this medicine. Do not use more medicine or use it more often than your doctor tells you to.
This medicine should come with patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Record and keep a treatment infusion log. This includes information, such as lot number, time, date, and any reactions.
Precautions
It is very important that your doctor check you 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 use it.
This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, lightheadedness, dizziness, or fainting, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you receive this medicine.
Alpha 1-PI is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from alpha 1-PI is very low and has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and testing during the manufacture of these medicines. Although the risk is low, talk with your doctor if you have concerns. Your doctor may give you a hepatitis B vaccine before receiving this medicine.
Side Effects
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
- Bladder pain
- bloody or cloudy urine
- body aches or pain
- chills
- cough
- difficult, burning, or painful urination
- difficulty with breathing
- ear congestion
- fever
- frequent urge to urinate
- headache
- loss of voice
- lower back or side pain
- runny or stuffy nose
- sneezing
- sore throat
- unusual tiredness or weakness
Rare
- Bloating or swelling of the face, arms, hands, lower legs, or feet
- blurred vision
- chest pain
- cough producing mucus
- diarrhea
- difficult or labored breathing
- dizziness
- feeling faint, dizzy, or lightheadedness
- flushing or redness of the skin, especially on the face and neck
- general feeling of discomfort or illness
- joint pain
- loss of appetite
- muscle aches and pains
- nausea
- nervousness
- noisy breathing
- pounding in the ears
- rapid weight gain
- shivering
- slow or fast heartbeat
- sweating
- tightness in the chest
- tingling of the hands or feet
- trouble sleeping
- unusual weight gain or loss
- vomiting
Incidence not known
- Confusion
- difficulty with swallowing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fast, pounding, or irregular heartbeat or pulse
- hives or skin rash
- itching, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
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
- Feeling of warmth
- itching skin
- muscle or bone pain
- pain or tenderness around the eyes and cheekbones
- redness of the face, neck, arms, and occasionally, upper chest
- sudden sweating
Rare
- Back pain
- bloating
- change in taste
- changes in vision
- fever
- loss of taste
- pain
- redness of the skin
- sleepiness or unusual drowsiness
- swelling of the joints
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
- welts
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.
DRG-20061630
