Immune Globulin (Panzyga)

면역글로불린([i MYUN GLOB yoo lin]으로 발음)은 Panzyga라는 상품명으로도 알려져 있습니다. 다른 여러 상품명으로도 판매되는데, 가장 흔한 상품명은 다음과 같습니다. Cuvitru, Gammagard, 가마스탄, 감마케드, 가무넥스-C, Hizentra, Hyqvia, Octagram, 그리고 Privigen, among many others. 면역글로불린 is a blood product derivative. Treatment with immune globulin is typically referred to as IVIG (intravenous immune globulin).

Panzyga는 어떻게 사용되나요?

Panzyga는 다음에서 승인되었습니다. 식품의약국(FDA) for males to treat many different types of cancers, including breast, head/neck, lung, cervical, prostate, bladder, ovarian cancer, and many more. It can be prescribed alone or with other medications simultaneously. Immune globulin contains IgG antibodies capable of opsonizing and neutralizing microbes and toxins. Immune globulin can be used for a wide variety of different conditions and diseases; however, the brand Panzyga is specifically used to: 

• 면역성 혈소판감소증(ITP) 치료
• Treat chronic inflammatory demyelinating polyneuropathy (CIDP)
• 예방하다 저감마글로불린혈증 (면역 체계가 약한 사람들의 다른 감염의 심각성을 멈추거나 낮추는 것)

사용 가능한 제형

Panzyga는 정맥 주입용 용액으로만 제공됩니다. 10ml, 25ml, 50ml, 100ml, 200ml, 300ml 등 다양한 용량으로 제공되며, 100mg/ml 농도를 함유하고 있습니다. 

사용 방법 

IVIG infusion can be administered as fast as 2 hours or as long as 24 hours, depending on disease state and severity. It should be administered in a separate infusion line from other medications. If a primary line is being used, flush with normal saline (NS) or dextrose 5 % in water (D5W) prior to administration. Decrease dose, rate, or concentration of infusion in patients who may be at risk of kidney failure. 

Panzyga dose varies depending on the disease state it is being used for. Typically, if the initial 30 minutes of the infusion is well-tolerated, the rate can be increased every 15 to 30 minutes as needed up to a maximum rate. Decreasing the rate or stopping the infusion may help relieve some adverse effects (flushing, changes in pulse rate, or blood pressure). Check with your physician about the rate and dose as well as the maximum rate allowed. 

복용량 누락

This medicine needs to be administered on a fixed schedule. If you miss a dose, notify your doctor, home health caregiver, or treatment clinic. 

저장

Panzyga can be stored in the refrigerator for up to 36 months from the date of manufacture. Within this time, it may be stored for up to 12 months at room temperature. Once the medication has been removed from the refrigerator and left at room temperature, it must be used or discarded. Do not return back to the refrigerator. It is recommended to remove it from the refrigerator prior to infusion. Store away from direct sunlight.

What To Avoid While Taking Panzyga?

Panzyga 치료를 받는 동안 몇 가지 예방 조치를 따라야 합니다. 이미 복용 중인 약물이 있다면 반드시 의사에게 알리십시오. 의사 또는 약사의 사전 동의 없이 약물이나 의약품(한약, 비타민 또는 일반 의약품 포함)을 복용하지 마십시오.. 이들은 Panzyga와 상당한 상호 작용을 할 수 있습니다. 

Pregnancy and Panzyga

Use of Panzyga may not be recommended if the patient is pregnant or breastfeeding. It could be potentially harmful to the fetus during pregnancy or to the infant while breastfeeding. It may be administered during pregnancy or while breastfeeding, but only if the potential maternal benefit outweighs the potential fetal risk. Consult with your physician if you think you may be pregnant or if you are breastfeeding.

부작용

As with any other medication, you may encounter side effects while taking Panzyga. A few things to remember are:

• 아래 나열된 모든 부작용이 나타나지 않을 수도 있습니다. 많은 사람들이 부작용을 거의 또는 전혀 경험하지 않을 수도 있습니다.
• The severity of side effects may vary from person to person, so don’t compare your side effects with other people’s experiences.
• 대부분의 부작용은 치료를 중단하면 호전됩니다.
• These side effects are easily manageable most of the time, either by readjusting the dose of Panzyga or using additional medications to treat the symptoms. Consult with your physician or pharmacist to explore available options.
• 어떠한 증상도 숨기지 마세요. 불편함을 느끼면 주저하지 말고 의사나 약사에게 알리세요. 

메모: 이 목록은 모든 부작용을 포괄하는 것은 아닙니다. 궁금한 점이 있으면 의사와 상담하세요. 

Some of the more serious side effects of Panzyga are listed below:

알레르기 반응/과민증

There have been cases reported of patients with allergic reactions to the Panzyga injection or any of its components. In addition, worsening asthma has been reported with therapy in patients with a history of asthma, sinusitis, or allergies. Signs of an allergic reaction can include rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; tightness in the chest or throat;  wheezing; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat. If you are experiencing any of these symptoms, seek emergency medical attention immediately. Immune globulin may not be recommended in patients with IgA deficiency.

Aseptic Meningitis Syndrome (AMS)

AMS has been reported with immune globulin administration. It is an illness characterized by serous inflammation of a certain area of the brain, most commonly causing headaches and fever. It more typically occurs with high doses or rapid infusion. AMS may appear within several hours to 2 days following treatment and usually resolves within several days after discontinuation. Female patients or patients with a migraine history may be at higher risk for AMS.

혈종 

The risk of hematoma formation is high if the immune globulin is administered subcutaneously for the treatment of immune thrombocytopenia.  

용혈

Hemolysis is the destruction or rupture of red blood cells. Intravenous immune globulin has been associated with hemolysis and can rarely lead to kidney impairment/failure. The risk for hemolysis may be increased if receiving high doses either as a single administration or divided over several days. Risk is also increased with underlying associated inflammatory conditions or non-O blood type. 

Blood Composition

Panzyga may affect elements in the blood, for example, by increasing protein or depleting sodium in the blood. 

Cardiac Complications

There is a risk that Panzyga may cause high blood pressure. It may typically present as a very bad headache or dizziness, passing out, or a change in eyesight. Less commonly, however, it can potentially lead to a condition called thrombosis if high blood pressure is left uncontrolled. In order to reduce risk, adequate hydration is highly recommended before infusion. Elevated blood pressure should be controlled with medications to treat high blood pressure. 

Infusion-Related Reactions

Risk for infusion-related reactions may be increased with initial treatment, when switching brands of immune globulin, or if treatment has been interrupted for more than 2 months. Infusion reactions may consist of fever and chills and may also include nausea, vomiting, pain, headache, dizziness, dyspnea, hypotension, rash, and weakness. If shortness of breath, swelling of the mouth or tongue, drop in blood pressure, or signs of infection occur, the infusion should be stopped immediately. If you experience a severe infusion reaction, the infusion can be re-attempted with appropriate premedications such as Tylenol or Benadryl. 

Pulmonary Edema

Panzyga can commonly cause fluid retention (also known as edema) within the lungs. In addition to pulmonary edema, immune globulin infusions can potentially lead to severe respiratory distress, hypoxemia (decreased levels of oxygen in the blood), and fever. 

Kidney Dysfunction/Failure

Short-term kidney dysfunction can rarely occur. Risk is increased in elderly patients, patients with preexisting kidney disease, diabetics, dehydrated patients, and concurrent users of other medications that may cause kidney harm. For those with higher risk, the dose, rate of infusion, and concentration of solution should be minimized. Adequate hydration prior to the infusion is highly recommended to minimize kidney damage. 

Other common side effects may include:

• 눈의 통증/시야 흐림
• 심박수 증가
• 탈모
• 현기증/피로
• 아메니아
• 허리/사지 통증
• 위장 불편
• 탈수
• Urine discoloration
• Chills/fever

Panzyga Dosing Information

Panzyga is available as: 10 ml, 25 ml, 50 ml, 100 ml, 200 ml, and 300 ml single-dose, ready-to-use vials at a concentration of 0.1 g/ml.

Panzyga is administered as an intravenous (IV) infusion only.

원발성 체액성 면역결핍증(PI)

Dose: The dose is 300 mg/kg to 600 mg/kg once every 3 to 4 weeks.

Infusion Rate: The starting infusion rate is 1 mg/kg/min (0.01 ml/kg/min) for at least 30 minutes. If there isn’t any evidence of infusion-related reactions, the infusion rate can be slowly increased every 15 to 30 minutes to up to 14 mg/kg/min (0.14 ml/kg/min).

Chronic Immune Thrombocytopenia (ITP)

정량: The dose is 1 g/kg once daily for 2 days.

Infusion Rate: The starting infusion rate is 1 mg/kg/min (0.01 ml/kg/min) for at least 30 minutes. If there isn’t any evidence of infusion-related reactions, the infusion rate can be slowly increased every 15 to 30 minutes to up to 8 mg/kg/min (0.08 ml/kg/min).

만성 염증성 탈수초성 다발신경병증(CIDP)

Dose: The dose is 1 g/kg once daily for 2 days, then a maintenance dose of 1 to 2 g/kg every 3 weeks, which is divided into 2 daily doses over 2 days. Based on the response to Gamunex-C, continued maintenance treatment after 6 months might not be necessary.

Infusion Rate: The starting infusion rate is 2 mg/kg/min (or 0.02 ml/kg/min). If there aren’t any infusion-related reactions, the rate can be slowly increased to a maximum of 8 mg/kg/min (0.08 ml/kg/min).

Panzyga 모니터링

Due to its many side effects, monitoring is an important part of managing Panzyga therapy. The following includes what you can expect with Panzyga use:

• 심장 모니터링을 위해 혈압을 정기적으로 측정해야 합니다.
• 특히 혈액 단백질과 나트륨 수치를 모니터링하기 위해 혈액 검사를 자주 실시해야 합니다.
• 특히 기존에 간 합병증이 있는 환자의 경우 간 기능을 모니터링해야 합니다. 
  • Panzyga may not be recommended in patients with severe liver impairment.
  • Some Panzyga formulations contain alcohol; the non-alcohol formulation would be less harmful to the liver.
• 일부 면역글로불린 브랜드(예: Panzyga)에는 소르비톨이 포함될 수 있으므로 환자에게 사용하지 마십시오. 유전성 과당 불내증 (HFI). Symptoms of HFI include recurrent vomiting, abdominal pain, and lower blood sugar.
• 환자는 심장 합병증, 특히 혈전증에 대해 모니터링을 받아야 합니다.
  • 혈전증의 위험은 나이가 많을수록, 장기간 부동상태일수록, 혈전증 병력이 있을수록, 에스트로겐을 사용할수록, 체내 카테터를 삽입할 경우, 혈액의 고점도(농축)일수록 증가합니다. 
  • 위험도가 높은 환자의 경우, 가능한 한 최소한의 용량과 주입 속도로 면역글로불린을 주입하는 것이 좋습니다.